chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Patient reports he woke up the day after the vaccination with temperature of 99.4, headache, body aches, fatigue, nausea, redness and soreness at injection site. Systemic symptoms improved over the next 3 days but pain and redness at the injection site worsened. Patient was seen in the office for evaluation on 4/28/18 and diagnosed with cellulitis at the injection site, treated with 7 day course of oral KEFLEX.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash 8 days after MMR.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Patient developed a blotchy, red rash from head to toe within moments of receiving the vaccines. Patient was given 2 ml of BENADRYL per doctor's orders. With 30 minutes of receiving BENADRYL rash began to disappear. Mom was informed to give another dose of BENADRYL before child was put to bed that evening. No additional follow ups were required.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Photosensitivity reaction, Pruritus
Clinical narrative: Within two hours after injection, all sun-exposed areas began to itch severely (face, neck, ears, upper chest, arms, hands  and ankles.)  A few small fluid filled pimples also appeared in some of these areas, they have since disappeared. (This was not sunburn.) Three weeks later and the itching continues, at times it is unbareable. It is quite bothersome on a daily basis even if I'm not in the sun, however, if any of these areas or new areas are exposed to the sun, the itching becomes much worse. I have never experienced any issues with photosensitivity or phototoxicity prior having this injection.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Adverse drug reaction, Injection site rash, Irritability, Urticaria
Clinical narrative: Patient presented with urticarial rash to neck, trunk, arms and upper left thigh. Mother reports she noticed 2-3 "spots" on his left thigh and hip area earlier this morning when changing his diaper. Since that time mother reports it has gotten worse. Patient is irritable.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Skin lesion
Clinical narrative: It has been 7 days since I received the vaccination and I am still dealing with fatigue, chills, sweats, soreness on the injection site, and several lesions on my face - one or which is the size of a quarter - that are continuing to spread.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT EXPIRIENCED LEFT ARM REDNESS, WARM TO THE TOUCH AND SWELLING. DIAGNOSED WITH CELLULITIS AND WAS TREATED WITH BACTRIM.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: PATIENT EXPIRIENCED LEFT ARM REDNESS, WARM TO THE TOUCH AND SWELLING. DIAGNOSED WITH CELLULITIS AND WAS TREATED WITH BACTRIM.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated multiple patients have reported large round welts after receiving SHINGRIX vaccine. The reporter did not have vaccine or patients information during the call and requested to be contacted at a later time when she was able to provide all the details about the patient, patient's experience and vaccine details.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Loss of consciousness, Pneumonia
Clinical narrative: PATIENT GOT UP OFF COUCH FROM LYING DOWN...WENT TO KITCHEN...PASSED OUT ONTO FLOOR FOR 5 SECONDS. AMBULANCE CAME AND TRANSPORTED PATIENT TO HOSPITAL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: The following day I experienced soreness at the injection site that lasted for about 5-6 days. For the first two days, I experienced fatigue. Lastly, about 2 days after the injection I developed redness at the injection site that lasted for several days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema
Clinical narrative: Day after vaccine, parent noted, left leg redness, swelling and tenderness. Patient seen by provider 3 days after vaccination and 10 cm X 6 cm, red area of edema, no induration or fluctuance noted. Hydrocortisone 2.5% cream prescribed, TYLENOL/MOTRIN recommended as needed.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Patient called at 9 am on 5/3/2018 reporting he had shivering, shaking, fever and pain at 1 am after receiving the IMZ at 9.45 am on 5.2.2018. I  advised him that these were some of the reactions noted on the VIS. The reactions should subside in 2 to 3 days. I advised him to also contact his physician.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyskinesia, Eye swelling, Fall, Fatigue
Clinical narrative: Patient called at 9 am on 5/3/2018 reporting he had shivering, shaking, fever and pain at 1 am after receiving the IMZ at 9.45 am on 5.2.2018. I  advised him that these were some of the reactions noted on the VIS. The reactions should subside in 2 to 3 days. I advised him to also contact his physician.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling cold, Hypotension, Pyrexia, Tongue disorder, Tremor
Clinical narrative: Patient called at 9 am on 5/3/2018 reporting he had shivering, shaking, fever and pain at 1 am after receiving the IMZ at 9.45 am on 5.2.2018. I  advised him that these were some of the reactions noted on the VIS. The reactions should subside in 2 to 3 days. I advised him to also contact his physician.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (strength, dose and route of administration were not reported) (lot # N029879, expiry date: 22-APR-2019) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiry date were reported as unknown). The vaccines were exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree F for a time frame of 45 minutes and 15 degree F to 46 degree F (32.01 degree F) for a time frame of 8.5 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Hyperhidrosis, Hypotension
Clinical narrative: Sixteen hours post dose 2 of SHINGRIX, I experienced SOB, feeling of pins and needles, and in some areas of my lungs nail-like sensations. I also experienced chest tightness. Believing at first that I may have been dehydrated due to the nature of my scleroderma, I drank almost a liter of water which I take with me bedside at night. This was at 0230. The pain intensified as I drank water but subsided somewhat in about 30 minutes, which decreased to about 7 on a scale of 1-10. I keep an albuterol inhaler in my nightstand and used 2 puffs every two hours. If the pain had intensified my plan was to have my husband take me to the ER or call for help, whichever was relative to my condition at the time. I did not sleep much between the outset of the event and 600 am when I got up and ate a small amount of cereal. I started to feel better in terms of breathing, still experiencing the sensation of pins, needles, and nails in my lungs. I felt well enough to attend a final physical therapy session for an ankle fracture, but was unable to complete the session due to SOB, weakness, hypotension with sweating. I was unable to drive; my husband drove me to and from the clinic. From 0800 this same day, I rested either sitting up or sleeping in bed. Around late afternoon I started to improve, pain down to 4-5 and able to swallow without pain. I am also a pharmacist. Believing it was not the vaccine at first because I did not have any reaction to dose 1 of SHINGRIX, I did not review any literature. But reviewing the package insert, contacting GSK this morning, I believe this may be the vaccine adjuvant. I am sensitive to certain plants and molds.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Insomnia, Paraesthesia, Pulmonary pain
Clinical narrative: Sixteen hours post dose 2 of SHINGRIX, I experienced SOB, feeling of pins and needles, and in some areas of my lungs nail-like sensations. I also experienced chest tightness. Believing at first that I may have been dehydrated due to the nature of my scleroderma, I drank almost a liter of water which I take with me bedside at night. This was at 0230. The pain intensified as I drank water but subsided somewhat in about 30 minutes, which decreased to about 7 on a scale of 1-10. I keep an albuterol inhaler in my nightstand and used 2 puffs every two hours. If the pain had intensified my plan was to have my husband take me to the ER or call for help, whichever was relative to my condition at the time. I did not sleep much between the outset of the event and 600 am when I got up and ate a small amount of cereal. I started to feel better in terms of breathing, still experiencing the sensation of pins, needles, and nails in my lungs. I felt well enough to attend a final physical therapy session for an ankle fracture, but was unable to complete the session due to SOB, weakness, hypotension with sweating. I was unable to drive; my husband drove me to and from the clinic. From 0800 this same day, I rested either sitting up or sleeping in bed. Around late afternoon I started to improve, pain down to 4-5 and able to swallow without pain. I am also a pharmacist. Believing it was not the vaccine at first because I did not have any reaction to dose 1 of SHINGRIX, I did not review any literature. But reviewing the package insert, contacting GSK this morning, I believe this may be the vaccine adjuvant. I am sensitive to certain plants and molds.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itchiness at site of injection. Redness is about 3.5cm in diameter and swelling about 4cm in diameter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Lymphadenopathy, Swelling
Clinical narrative: Swelling, warmth 2 days after injection, then swollen lymph node 3 days after injection.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back to pharmacy with redness and swelling at injection site that has lasted longer then 2-3 days as stated by GSK. Patient is not in pain and its not itching - just red and hot to touch.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back to pharmacy with redness and swelling at injection site that has lasted longer then 2-3 days as stated by GSK. Patient is not in pain and its not itching - just red and hot to touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Bullous reaction at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Rash at site after injection given. Fever noted 7-9 days later with rash. (Thus was his first time receiving MMR and varicella vaccines). Mom also gave peanut soup but he has had this before without incident.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. The reporter considered the localized erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was placed on phone by retired GSK employee. She states another female worker at the store received SHINGRIX and had a red streak from the top of her shoulder down to the injection site. No other details were known. Encouraged to have individual contact GSK to report events as well, and it was a follow up call. The caller was cashier at pharmacy. This case has been linked with US2018071883 and US2018071881, reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, general body pain and rash. On an unknown date, the outcome of the fever, general body pain and rash were unknown. It was unknown if the reporter considered the fever, general body pain and rash to be related to SHINGRIX. Additional details were reported as follows: The case was reported on a social media account by a person that the reporter knows and she reported it to all her social media followers. Two days after vaccination the patient had Rash on both arms at inner elbow. The events did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporter consider the events to be life threatening or to result in persistent or significant disability or incapacity. The patient did not die. The events did not require surgical or medical. The events did not result in a congenital anomaly or birth defect. The reporter did not speak with the patient directly nor corresponded in any way with the patient. The reporter had no other detail.
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Fatigue, Headache, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a day after receiving Flu trivalent vaccine, the patient experienced general body pain, headache, exhaustion and sickness. On an unknown date, the outcome of the general body pain, headache, exhaustion and sickness were recovered/resolved. The reporter considered the general body pain, headache, exhaustion and sickness to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 11 years before the reporting date, the patient received an influenza vaccination of unknown manufacturer. Within a day of being vaccinated, the patient was sick and bedridden with symptoms of body aches, headache, a feeling of being totally exhausted like she was going to die for at least one day. Then she felt like she really tired recovering from the flu, and all the symptoms were eventually resolved. The patient did not recall the exact timeline for symptoms or any further specific product dosing details. The patient thought that, the flu vaccine caused all of those symptoms and decided not to have any further flu vaccinations since. This case has been linked to case US2018070982, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Swollen tongue, Tachycardia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tachycardia in a elderly female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included iodine allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified at an unknown dose. On an unknown date, less than an hour after receiving Influenza vaccine Quadrivalent, the patient experienced tachycardia, tingling tongue and swollen tongue. On an unknown date, the outcome of the tachycardia, tingling tongue and swollen tongue were recovered/resolved. It was unknown if the reporter considered the tachycardia, tingling tongue and swollen tongue to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have an egg allergy. The patient received the influenza vaccine 4 to 5 years before the date of reporting (the healthcare professional was unsure which brand) and in less than 5 minutes after receiving vaccination, the patient experienced a reaction of tachycardia and tongue felt unusual (tingly and swollen). The events resolved within 5 minutes. The patient did not have any breathing or swallowing difficulty. The patient did not receive the flu vaccine since then.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a adult female healthcare professional who intended to vaccinate a patient with SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional who was pregnant, suffered a needle stick while preparing a dose of SHINGRIX for administration. The healthcare professional declined to provide any further information including address.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pneumonia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pneumonia in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the pneumonia was not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the pneumonia to be related to SHINGRIX. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms which resolved after 2 days. The patient was later diagnosed with pneumonia. The patient stated pneumonia had not resolved after a month. The healthcare professional did not collect patient or vaccine data. The information was given to the reporter in passing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Local reaction, Skin lesion
Clinical narrative: Large 5 inch lesion at site. Started 1D after administration. Severe local reaction - no anaphylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site rash. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site rash to be related to SHINGRIX. Additional details were provided as follows: Event reported on after hours voice mail. The age at vaccination was not reported. The symptoms lasted for approximately about 5 days. No further information was obtained due to limited contact with the reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Pruritus
Clinical narrative: Joint pain. Itching - no visible rash. General discomfort.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Tremor
Clinical narrative: After completion of visit but before leaving clinic, pt reported feeling dizzy after getting Hep A/B vaccine. Reported dizziness, then later shakiness "like shaking under my skin." Never had this reaction after a vaccine before, says she only had this after an epinephrine injection. Denied shortness of breath, tongue selling, difficulty breathing or swallowing, itching, hives. On exam, lungs CTA, throat non-edematous, skin without rash/hives. Pt was monitored in the clinic, BP while symptomatic was 126/79. Pt's brother was coming to pick her up. Advised that since clinic will be closing, she could go to ER for observation. However she declined, prefers to have her brother take her home. I am suspicious that this is a vasovagal reaction, no e/o allergic reaction at this time, so I think this is reasonable. Educated pt on s/s of severe allergic reaction, advised to have someone stay with her the rest of the evening and go directly to ER if experienced. Pt verbalized understanding, feels safe with this plan. Called pt at 6:30pm, she says she is resting, still feels a little shaky but no new symptoms. Her daughter is there with her, they are about to eat dinner. Tells me she hasn't eaten since breakfast, trying to lose weight. I advised her to eat something, stay hydrated, and maintain same precautions as before.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient experience severe chills with a low grade fever 11 hours after receiving the vaccine.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: EXTREMELY PAIN AT INJECTION SITE. INJECTION SITE RED AND SWOLLEN AND HOT TO THE TOUCH PAIN RADIATING DOWN ARM TO HAND AND UP SHOULDER. FEVER. MALAISE. FLU LIKE SYMPTOMS.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: EXTREMELY PAIN AT INJECTION SITE. INJECTION SITE RED AND SWOLLEN AND HOT TO THE TOUCH PAIN RADIATING DOWN ARM TO HAND AND UP SHOULDER. FEVER. MALAISE. FLU LIKE SYMPTOMS.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: EXTREMELY PAIN AT INJECTION SITE. INJECTION SITE RED AND SWOLLEN AND HOT TO THE TOUCH PAIN RADIATING DOWN ARM TO HAND AND UP SHOULDER. FEVER. MALAISE. FLU LIKE SYMPTOMS.
Age: 48.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: EXTREMELY PAIN AT INJECTION SITE. INJECTION SITE RED AND SWOLLEN AND HOT TO THE TOUCH PAIN RADIATING DOWN ARM TO HAND AND UP SHOULDER. FEVER. MALAISE. FLU LIKE SYMPTOMS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Headache, Neck pain, Pain in extremity
Clinical narrative: Pt describes significant arm pain, sore neck pain in temple area, and eyes fluttering.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: The whole upper body broke out in a rash. After 48 hours the rash was completely gone. It was a red rash, the patient was not itchy at all.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 28 year old female patient. The patient's medical history and concurrent conditions were not reported. On 18-APR-2018, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, intramuscularly, lot # M035388, expiration date: 19-APR-2018, rHA (recombinant Human albumin), for prophylaxis. Concomitant medications were not reported. On 18-APR-2018, the patient experienced an unspecified injection site reaction. At the time of reporting, the outcome of injection site reaction and the relatedness between the injection site reaction and M-M-R II were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye irritation, Eye pain, Herpes zoster, Keratitis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on 16-JAN-2014 for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately January 2014 [reported as shortly after receiving ZOSTAVAX], the patient developed irritation, inflammation, and pain in his left eye. Thereafter, the patient presented to an optometrist and was diagnosed with herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea. As a direct and proximate result of these malfunctions, 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 is unknown. Upon internal review, herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on 16-JAN-2014 for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately January 2014 [reported as shortly after receiving ZOSTAVAX], the patient developed irritation, inflammation, and pain in his left eye. Thereafter, the patient presented to an optometrist and was diagnosed with herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea. As a direct and proximate result of these malfunctions, 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 is unknown. Upon internal review, herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on 08-JUN-2012 at a pharmacy, for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately June 2012 [reported as shortly after receiving the ZOSTAVAX vaccine], the patient developed severe and painful itching on the left side of her chest and on her back. Thereafter, the patient presented to a physician and was diagnosed with shingles. As a direct and proximate result of these malfunctions, 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 is unknown. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 75-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included chronic obstructive pulmonary disease and asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had received 2-3 PNEUMOVAX 23 vaccinations before the age of 65. He received a booster of pneumococcal vaccine polysacch 23V after 70 and did not fully respond. The patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) within 5 months of pneumococcal vaccine polysacch 23V. On unspecified date, the titers still came back low after pneumococcal 13-val conjugate vaccine (dipht crm197 protein). The outcome of the event was unknown. The physician revaccinated the patient with pneumococcal 13-val conjugate vaccine (dipht crm197 protein). Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient (Age approximately 66; Unit: Unknown)of an unspecified ethnicity received the first single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, fatigue on an unspecified date (occurred 2 days after vaccination) and other reactions listed in PI Reactions resolved after one week. The outcome of events fever and fatigue was unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient stated she experience "severe" body aches. She also "broke out" on her face.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient received vaccine in clinic on April 17 and felt some soreness which subsided by end of next day. On April 30 she woke up and felt soreness in the same arm and worried it might be from the vaccine.  She returned to the clinic on May 3, 2018 to ask about soreness. Soreness had abated. Only sore when she pushed on it. No abnormal temperature or fever. Denied shortness of breath or any other symptom. Patient stated that cause "might also be sleeping wrong." No color or swelling noted at injection site. Patient notified that we would complete a VAERS report and to call 911 or return to clinic if symptoms didn't subside in next few days.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Pruritus generalised, Throat tightness
Clinical narrative: PATIENT STATED THAT AFTER LEAVING HERE ON 04/03/2018 SHE BEGAN TO ITCH ALL OVER HER BODY AND FELT LIKE HER THROAT WAS CLOSING UP. THE REACTION WAS SO SEVERE THAT SHE CALLED 9-1-1.  SHE SAID THE PARAMEDICS GAVE HER BENADRYL AND AFTER A WHILE SHE WAS OK.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dyskinesia, Excessive eye blinking, Tic
Clinical narrative: These symptoms began 4weeks ago. Other comments include: She began with eye blinking, then moving the nose, and now also moves mouth side to side. There is no specific trigger per mom. She could just be watching tv and it occcurs.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Insomnia, Malaise, Myalgia
Clinical narrative: Beginning less than 12 hours after injection, despite taking a naproxen, had myalgias, malaise, low-grade fever (100 degrees), skin sensitivity to touch, headache. Symptoms made sleep difficult, Gradually improved over the next day, but headache and skin sensitivity persisted.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Beginning less than 12 hours after injection, despite taking a naproxen, had myalgias, malaise, low-grade fever (100 degrees), skin sensitivity to touch, headache. Symptoms made sleep difficult, Gradually improved over the next day, but headache and skin sensitivity persisted.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Symptoms: nausea, fever, headaches, chills, sore arm; Pregnancy info: 28 weeks, due date 7/23/18, this is my second pregnancy. I had Tdap with first child and had similar reaction but not as bad as this time. First child is currently 2 years 9 months
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash generalised, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 65-year-old female patient who received SHINGRIX. Concomitant products included CALTRATE, Multi Vitamin and SYMBICORT. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, 10 hrs after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the patient experienced raised rash. The patient was treated with Steroids and BENADRYL. On an unknown date, the outcome of the generalized rash was recovering/resolving and the outcome of the raised rash was unknown. The reporter considered the generalized rash and raised rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Ten to twelve hours after receiving SHINGRIX, the patient experienced rash all over which was more pronounced and inflamed on Sunday and Monday. The physician prescribed steroids and the patient took BENADRYL and the rash was not as inflamed. The patient reported that the rash was more prominent on her trunk and arms which was very slight, raised and inflamed and the rash spread to both of her thighs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: About a week after getting the SHINGRIX vaccine, Patient reported that she was diagnosed with shingles.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection in left upper arm, left upper arm and shoulder swelling to the point of being un-moveable , hard to the touch and very red around the edges of the swelling (from shoulder to midpoint of shoulder and elbow) Took 440mg. Naproxen and applied hot compress in the evening. By morning the swelling had subsided by about half. By end of 2nd day the swelling had subsided completely but was still tender to the touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Soreness in arm, nausea, dizziness, aches and pains, headache, severe chills and 102 degrees fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm, nausea, dizziness, aches and pains, headache, severe chills and 102 degrees fever.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event. Received Hepatitis A vaccine and was not due for it until September 2018 (additional dose). NO treatment, no injury.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Mom reports that the day following the vaccines he had a small circular area of redness and swelling but the next day he woke and he had an area 7"x5" of redness, swelling, slightly firm to touch and warm. The area of redness was marked. He was seen back at the clinic and family was advised to use Ibuprofen 5 tsp every 6-8 hours as needed, BENDRAYL 3 tsp every 6-8 hours as needed, apply ice to the area and the physician did call in some KEFLEX for 5 days. Family is to follow up by phone on Saturday sooner in the office if things are worsening.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain, Pain, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included atenolol, clopidogrel, Levothyroxine and simvastatin. On 20h April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, erythromacular rash and pain. On 24th April 2018, the patient experienced blister. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythromacular rash, pain and blister were not recovered/not resolved. The reporter considered the injection site pain, erythromacular rash and pain to be related to be related to SHINGRIX. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX vaccine at the pharmacy. The patient complained of having pain in the arm where she received the injection. The patient also experienced about 4 red spots that are also painful. These symptoms developed the next day after the injection. The patient also said that, at the time of reporting, 4 days after vaccination she woke up with blisters above her lips. The patient thinks it might be the SHINGRIX. The blisters were not open.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty breathing and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms and difficulty breathing were unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, difficulty breathing and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced terrible flu like symptoms and could not raise her arm for two days. The patient also had difficulty breathing. This information was communicated while the reporter was reporting her own adverse events with the product. The reporter was transferred to Medical Information for additional assistance. This case was linked to the case US2018071812, reported by the same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Headache, Hypoaesthesia, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 50-year-old female patient who received SHINGRIX. Concomitant products included doxycycline, gabapentin, vitamin D, diclofenac sodium, estradiol and CLARITIN D. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, 1 days after receiving SHINGRIX, the patient experienced hives. On 17th April 2018, the patient experienced Bell's palsy (serious criteria GSK medically significant), headache and numbness. The patient was treated with prednisone and Valacyclovir. In April 2018, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the Bell's palsy, headache and numbness were recovering/resolving. The reporter considered the Bell's palsy, hives, headache and numbness to be related to SHINGRIX. Additional details were reported as follows: This case was received via email. This case was already reported to a doctor. The age at vaccination was not reported. The patient's concomitant medication included multivitamins. The parent medical history included, breast cancer (diagnosed in July 2017) for which double mastectomy surgery was performed in September 2017. The patient received SHINGRIX on left arm. Three days after receiving SHINGRIX, the patient experienced terrible pain on left side of head, numbness, droopy mouth and possible Bell's palsy. The patient stated that, she went to the emergency room and the doctor prescribed her with prednisone and valacyclovir for possible Bell's palsy. The reporter did not provide any additional information. The patient denied permission to contact their physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pruritus, Skin warm
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX (batch number XC534, expiry date unknown). On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, headache, pruritus and skin warm. On an unknown date, the outcome of the fatigue, headache, pruritus and skin warm were unknown. It was unknown if the reporter considered the fatigue, headache, pruritus and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient was a pharmacist and understood vaccines. The patient experienced crushing fatigue, headache and itching and her arm was still hot one week later. The reporter thought that this was vaccine related to worried that the non pharm D patient who experiences this will not return for dose 2.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Rash
Clinical narrative: Urticaria at injection site (R) thigh noted shortly after vaccines given. "BENADRYL given". Rash was resolving by time baby left clinic.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 59-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain and fever. In April 2018, the outcome of the pain and fever were recovered/resolved. The reporter considered the pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The physician stated the patient's symptoms were severe but not disabling, and the patient almost stayed home from work due to the symptoms. The patient did not require a doctor visit, emergency room visit or hospitalization.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test, Dizziness, Echocardiogram, Malaise
Clinical narrative: This spontaneous report was received from a consumer referring herself as a female patient of currently 80 years old. The patient concurrent conditions included shingles, high blood pressure and hypothyroidism. The patient's medical history was not reported. The patient was allergic to latex and penicillin. The patient's concomitant medication included losartan and levothyroxine. On an unknown date, approximately back in 2006 to 2007, the patient was vaccinated with ZOSTAVAX (0.65 ml, frequency not reported) (lot# and expiration date not reported) subcutaneously. On an unknown date, reported as within a year of getting vaccination, the patient experienced dizzy spells (dizziness), blood pressure went up like crazy (blood pressure increased) and had pins and needles in both of feet, middle of back and down of arms and hands. It was also reported that, the patient was in constant pain and reported that it was been horror (pain). The patient have seen multiple neurologists and given with couple of unspecified shots in back to numb it, but patient was suffering. The patient received tramadol for pain, but patient got violently ill with vomiting and dizziness and stopped taking it. Patient also stated that, unspecified blood tests and echocardiogram were performed to the patient, but results were not provided. The patient was not recovered from the events. The reporter did not provide the causal relationship for the events with suspect therapy ZOSTAVAX. No product quality complaint was involved.