chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Pain in extremity, Rash, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of infection in a 81-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced infection, swelling, rash and pain in arm. The patient was treated with nutritional supplement (Probiotics). On an unknown date, the outcome of the infection, swelling, rash and pain in arm were unknown. It was unknown if the reporter considered the infection, swelling, rash and pain in arm to be related to SHINGRIX. Additional information were provided as follows: The reporter stated that, she was provided with information about possible rash but no photo of how the rash would looked like. As anticipated, the patient had pain in arm and swelling along with a developing rash. The reporter stated that her arm was began to swell far more and over the next tow day the rash grew much larger. On 22nd April 2018, though still uncertain if the swelling and rash were in the normal range, she decided to go to the emergency room where it was determined that she had an infection. The course of antibiotics started along with a course of probiotic. The reporter call the pharmacy where the vaccine was given and asked if they had any policy to cover costs expenses as a result an infection due to their shot. It was suggested they the reporter should contact GlaxoSmithKline directly. The reporter stated that the cost of antibiotics was not great and the probiotics were some she had in the house (though she would have to buy a new box of probiotics), but they also had to spend time and gas traveling to the hospital and next day to the pharmacy. The reporter hoping that GlaxoSmithKline might have a policy that fairly reimbursed a client who wound up with unexpected bills because of an infection that resulted from shot given by pharmacy. This case was linked with US2018GSK076230, reported by the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that on 19-SEP-2017, the patient received the first dose of GARDASIL 9 (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. Subsequently, on 14-MAR-2018, the patient received an expired second dose of GARDASIL 9 (lot number M020103, expiration date 15-FEB-2018) (strength, dose, frequency, route of administration, and anatomical location) for prophylaxis (Inappropriate schedule of drug administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash, Visual impairment
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 or about 26-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed headaches, painful rashes on both her legs and waist, along with a reduction in her eyesight. Thereafter, the patient presented to her primary care group 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: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Chest pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable Registered Nurse. A 65-year-old female patient received PREVNAR 13, (Lot # T36368, Expiry Date 31Jan2020) intramuscular at 0.5 ml, single at right deltoid on 18May2018 at 10:30 for immunization, administered at physician office. The patient medical history and concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications, other medical conditions or relevant investigations to provide. No additional vaccines administered on same date of PREVNAR 13. No prior vaccinations (within 4 weeks). The patient was anxious on 18May2018 with outcome of unknown, experienced localized swelling at injection site that is the size of a softball on 22May2018 (or on 24May2018 as also reported) with outcome of not recovered, chest pain on 20May2018 with outcome of unknown, rash on 24May2018 with outcome of unknown, itching and warmth at injection site on 24May2018 reported as worsened, palpitations on 24May2018 with outcome of unknown. The events required a visit to Emergency Room and Physician Office. Course of events: The patient went to the ER twice and to the physician's office twice. The ER reported on 20May2018 indicating there were no acute findings. The patient reported a rash prior to the ER visit on the 24th. The itching, warmth and palpitations occurred about 20 minutes after the injection. The patient noticed the onset of itching and warmth at area about 20 minutes prior to her appointment with primary care doctor on 24May2018. The reporter added that the patient has an area the size of a softball with swelling at injection site. The reporting nurse assessed all events as Medically significant. Relatedness was reported as unknown for all events. Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of being anxious, localized swelling at injection site, chest pain, rash, itching and warmth at injection site and palpitations cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Palpitations, Rash
Clinical narrative: This is a spontaneous report from a contactable Registered Nurse. A 65-year-old female patient received PREVNAR 13, (Lot # T36368, Expiry Date 31Jan2020) intramuscular at 0.5 ml, single at right deltoid on 18May2018 at 10:30 for immunization, administered at physician office. The patient medical history and concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications, other medical conditions or relevant investigations to provide. No additional vaccines administered on same date of PREVNAR 13. No prior vaccinations (within 4 weeks). The patient was anxious on 18May2018 with outcome of unknown, experienced localized swelling at injection site that is the size of a softball on 22May2018 (or on 24May2018 as also reported) with outcome of not recovered, chest pain on 20May2018 with outcome of unknown, rash on 24May2018 with outcome of unknown, itching and warmth at injection site on 24May2018 reported as worsened, palpitations on 24May2018 with outcome of unknown. The events required a visit to Emergency Room and Physician Office. Course of events: The patient went to the ER twice and to the physician's office twice. The ER reported on 20May2018 indicating there were no acute findings. The patient reported a rash prior to the ER visit on the 24th. The itching, warmth and palpitations occurred about 20 minutes after the injection. The patient noticed the onset of itching and warmth at area about 20 minutes prior to her appointment with primary care doctor on 24May2018. The reporter added that the patient has an area the size of a softball with swelling at injection site. The reporting nurse assessed all events as Medically significant. Relatedness was reported as unknown for all events. Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of being anxious, localized swelling at injection site, chest pain, rash, itching and warmth at injection site and palpitations cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Bursa injury, Inflammation, Ligament injury, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt. claims after 1 day or so, he was unable to raise his arm. Pt. was seen by several Dr. to help relieve pain and inflammation. After seeing an orthopedic and MRI, pt. was told there was injury to bursa sac and ligaments. Pt. was told injury was possibly from vaccine administration.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pt. claims after 1 day or so, he was unable to raise his arm. Pt. was seen by several Dr. to help relieve pain and inflammation. After seeing an orthopedic and MRI, pt. was told there was injury to bursa sac and ligaments. Pt. was told injury was possibly from vaccine administration.
Age: 21.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Cough, Polymerase chain reaction, Pruritus, Pyrexia, Rash
Clinical narrative: Rash on forehead, back of neck, chest/stomach (itchy). Fever up to 103. Upper respiratory S/S of coughing.
Age: 21.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Respiratory symptom, Viral test negative
Clinical narrative: Rash on forehead, back of neck, chest/stomach (itchy). Fever up to 103. Upper respiratory S/S of coughing.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Lymph node pain, Lymphadenitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Previously administered products included SHINGRIX with an associated reaction of injection site erythema (received 1st dose of SHINGRIX on 6th March 2018, for tolerance see case US2018087770). Concomitant products included ASACOL, EFFEXOR SR, PORTIA 28 and SYNTHROID. On 15th May 2018 09:00, the patient received the 2nd dose of SHINGRIX. On 15th May 2018 16:00, 7 hrs after receiving SHINGRIX, the patient experienced injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. On 15th May 2018, the patient received SHINGRIX at 9:00. At 16:00 hours, the patient experienced itching near the injection site, which spread to the elbow. The patient also experienced redness, a warm sensation at the injection site, stiffness and soreness on glands of her neck, left side, and under her left arm gland. At time of reporting, the events was not resolved. The patient was vaccinated at her place of work. This case has been linked with case US2018087770, reported by the same reporter for the same patient.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Lymph node pain, Lymphadenitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included ASACOL, EFFEXOR SR, PORTIA 28 and SYNTHROID. On 6th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the injection site itching lymph node pain, axillary adenitis, injection site erythema and injection site warmth to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. This case was previously reported to the doctor. The patient received SHINGRIX and approximately 6 hours later, the patient reported that experienced itching near the injection site, which spread to the elbow. The patient also experienced redness, a warm sensation at the injection site, stiffness and soreness on glands of her neck, left side, and under her left arm gland. This case has been linked with case US2018GSK096035, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that the patient received 1st dose of SHINGRIX and went to her physician on 20th May 2018. The patient's physician diagnosed patient with shingles and prescribed anti-viral medication. The caller did not had additional details during the call.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX. Concurrent medical conditions included cataract (left eye surgery performed on 9th May 2018 and right eye surgery was scheduled on 23rd May 2018). Concomitant products included ADVIL, simvastatin, BESIVANCE, and PROLENSA. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient's body temperature went as high as 100.7 degree F. The patient planned to follow up with his physician on an unknown date.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a elderly male patient who received SHINGRIX. Concomitant products included CARDIZEM CD, vitamin E and danazol. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. The reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant products included Vitamins. The reporter was the physician who received vaccine. The patient received vaccine on left deltoid. The next day after receiving the SHINGRIX, he experienced injection site tenderness which lasted for 3 or 4 days then resolved. The reporter stated that his doctor changed jobs and took 1 month off so he should be available at this phone number and facility after 1st June 2018.
Age: 30.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: The patient states that she had urticaria on each arm from the shoulder down to her wrist and on the top of each hand. As well as urticaria on her front of her abdomen. She stated she took a cold shower and used over the counter hydrocortisone cream to treat the affected area. Symptoms lasted approximately one hour.
Age: 30.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: The patient states that she had urticaria on each arm from the shoulder down to her wrist and on the top of each hand. As well as urticaria on her front of her abdomen. She stated she took a cold shower and used over the counter hydrocortisone cream to treat the affected area. Symptoms lasted approximately one hour.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Patient came to counter and said she had rxn to vaccine from yesterday, defined swelling in entire upper arm down  to elbow and into shoulder. Hot to the touch, and painful.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Muscular weakness
Clinical narrative: Client called for test results and commented that "My arms felt weak for two weeks". "After I gave you your shots?" I asked? "Yea, it felt like I had been fishing hard" - which to me means, as a fisherman, his arms felt overworked, tired, sore, limited range of movement. Client told me he was improved now. No symptoms.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria, Vaccine positive rechallenge
Clinical narrative: After receiving SHINGRIX vaccines on 2/19/18 and 5/23/18, he developed patchy erythematous, itchy, urticarial rash on chest and arms. After the first immunization, the rash lasted for several weeks, then gradually resolved. The rash reappeared within a day of receiving second vaccine in the series. No accompanying systemic symptoms, including no respiratory symptoms, angioedema, faintness or GI symptoms.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fall, Fatigue
Clinical narrative: Chronic full body muscle weakness, chills, hip joint soreness, fatigue, Fell in bedroom Tuesday 05/29/18, pre-dawn, unable to get up for appx an hour. Fell in bathroom Thursday 05/31/2018, 6:30am, unable to get up until 7:30am. No strength to get up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Chronic full body muscle weakness, chills, hip joint soreness, fatigue, Fell in bedroom Tuesday 05/29/18, pre-dawn, unable to get up for appx an hour. Fell in bathroom Thursday 05/31/2018, 6:30am, unable to get up until 7:30am. No strength to get up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Influenza, Productive cough, Respiratory tract congestion
Clinical narrative: Shortness of breath, chest congestion, Flu symptoms, productive cough.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Cough, Rhinorrhoea, Sneezing, Sputum discoloured
Clinical narrative: Shortness of breath, chest congestion, Flu symptoms, productive cough.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Upper-airway cough syndrome
Clinical narrative: Shortness of breath, chest congestion, Flu symptoms, productive cough.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face
Clinical narrative: Facial swelling.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Several 'pox-like' lesions formed which have not completely healed at this time.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on trunk and neck. Itching. Started day after immunization, not known if progressing. Advised to take BENADRYL and contact MD or urgent care if worsens.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever of 102.0 approx 24 hours after injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Fever, chills, joint pain severe enough to prevent sleep, injection site pain of course. Flu like symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, joint pain severe enough to prevent sleep, injection site pain of course. Flu like symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported adverse reaction on 05/31/2018. Patient states that beginning night of vaccination (05/30/18) her upper right arm began to swell, became red, warm to the touch and achy. Patient states that she iced the injection site night of vaccine. Patient called pharmacy the next morning, around mid-morning to report reactions. Patient stated that she was still having pain at injection site, redness, swelling, area was warm to the touch. Patient was advised to monitor for signs of infection and to call MD if she began to experience any symptoms described to her by pharmacist signifying infection. Patient was advised by pharmacist to take ibuprofen, BENADRYL by mouth and ice are as needed.
Age: 60.0
Sex: M
Vaccine: RAB
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pt was exposed to rabid bat on 5/7, started Rabies vaccine and RIG on 5/10. Pt  noted, at the time of injection, that this vaccine was the most painful, (had 13 ml of RIG-at other sites) of the other vaccines. On subsequent vaccines of Rabies, he did not have the same degree of discomfort. The evening of the original vaccine, he complained of pain in the R shoulder, noting decreased ROM.  The decreased ROM, perceived weakness and pain have persisted for the last 3 wk, but vaccines administered at other sites are not. Pt reports he is unable to reach up to push his garage door opener. Pt notes that he has difficulty raising the R arm higher than his shoulder.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Has localized swelling and redness with pain. Home care of BENADRYL, MOTRIN and cold compress.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Scar
Clinical narrative: Patient said they developed some shingles on their left arm and a small amount on the right arm.  The symptoms where some itching and pain especially in sunlight. It lasted for about 2 weeks. The patient did not go to the doctor and waited for them to go away on their own. The patient had some minor scar that was visible at today's vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Administration site pain, Chills, Fatigue, Insomnia, Pain
Clinical narrative: Pain at site of administration (left arm) was noticeable within approx. 4 hours; within 15 hrs. the pain was so pronounced that sleeping was interrupted / difficult. Also had significant chills during the first night; I started taking 400mg of ibuprofen and continued every 4 hours for the next day, which helped. The next day included general body aches, not only left arm (vaccination site) but the entire arm as well as my right arm and both legs. Overall body aches persisted throughout the 2nd day (Wednesday 4/11) so I continued ibuprofen; generally felt tired. Body aches / fatigue continued on Thursday 4/12, so I periodically took 400 mg of ibuprofen. Resolved by 4/13.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain at site of administration (left arm) was noticeable within approx. 4 hours; within 15 hrs. the pain was so pronounced that sleeping was interrupted / difficult. Also had significant chills during the first night; I started taking 400mg of ibuprofen and continued every 4 hours for the next day, which helped. The next day included general body aches, not only left arm (vaccination site) but the entire arm as well as my right arm and both legs. Overall body aches persisted throughout the 2nd day (Wednesday 4/11) so I continued ibuprofen; generally felt tired. Body aches / fatigue continued on Thursday 4/12, so I periodically took 400 mg of ibuprofen. Resolved by 4/13.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given pediatric dose instead of Adult dosage.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Miliaria, Pruritus, Rash
Clinical narrative: The morning of the day after vaccination, developed what looked/felt like a heat rash on neck, extending to throat, beneath chin. Included redness, and with small hive-looking to small blister-like bumps that itch. Worsened when outdoors (90 degrees F) in direct sun OR in shade. Three days ago, spread to chin and around mouth. Accompanied by headache the first morning rash occurred. It's now been two weeks, and persists. Took a BENADRYL (antihistamine), with no change or effect. Applied CORTIZONE ointment, with no effect. Visited dermatologist today, 5/31/2018, who, honestly, was no help. Wasn't familiar with SHINGRIX, so couldn't offer opinion whether or not the cause. I believe it's related to vaccine due to timing and after reading "side effects" on manufacturer's website.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Urticaria
Clinical narrative: The morning of the day after vaccination, developed what looked/felt like a heat rash on neck, extending to throat, beneath chin. Included redness, and with small hive-looking to small blister-like bumps that itch. Worsened when outdoors (90 degrees F) in direct sun OR in shade. Three days ago, spread to chin and around mouth. Accompanied by headache the first morning rash occurred. It's now been two weeks, and persists. Took a BENADRYL (antihistamine), with no change or effect. Applied CORTIZONE ointment, with no effect. Visited dermatologist today, 5/31/2018, who, honestly, was no help. Wasn't familiar with SHINGRIX, so couldn't offer opinion whether or not the cause. I believe it's related to vaccine due to timing and after reading "side effects" on manufacturer's website.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Patient stated that his arm was extremely swollen the next day (size of a baseball in deltoid muscle that immunization was administered in). He also stated that every muscle in his body hurt the following day. Patient did not endorse any fever or other symptoms. Symptoms resolved within 24 hours.
Age: 73.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Patient reports itching on his back approximately 3 days post vaccination. His wife confirmed there was no discoloration at that time. By the 27th, patient noticed a red itchy rash under his left armpit.  Within another day, vesicles started to form and he sought medical treatment. Appointment today confirmed that patient has a active shingles outbreak and patient is receiving anti-virals.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: MOM STATES THAT CHILD DEVELOPED A KNOT AT INJECTION SITE WHICH WAS RED AND SWELLING SPREAD THROUGH LEG.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: 8cm x 7cm area of erythema, slight bogginess, warmth -- NONtender.
Age: 58.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Myalgia
Clinical narrative: Muscle soreness in both arms with the left arm being worse than the right. I'm still having the muscles soreness today with the left arm worse. It was initially some minor soreness and then I had another shot on 1/29/18 which was Zoster with brand name ZOSTAVAX. I had Hepatitis B ENGERIX B second dose on 2/26/18. I also took Typhoid Live oral ty21a VIVOTIF during the end of Feb. The soreness continued to get worse in March and has been a constant aching since.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site pain, Pain in extremity
Clinical narrative: DIFFICULTY BREATHING. PAIN IN LEGS AND AT INJECTION SITE. EMERGENCY ROOM VISIT.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Localized Swollen, Red, Hot to the touch, hard.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Night sweats, Pyrexia
Clinical narrative: Fever of 101 starting the day of shot, night sweats, lethargy -  all symptoms resolved after 2-3 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: About 12 hours later skin turned bright red (like severe sunburn) all over chest, stomach, back, inside arms, up neck, sides of face (not legs). Hot to the touch, no glands swelling - peaked at 2 days post vaccine then started subsiding on day 3.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Rash, Rash pruritic, Skin warm
Clinical narrative: PATIENT WAS ADMINISTERED BOOSTRIX ON 05/24/18. SHE DID NOT HAVE ANY REACTIONS/SYMPTOMS UNTIL MONDAY (05/28/18), WHEN SHE NOTICED ITCHY RASH ON HER STOMACH, THIGHS AND FOREARMS WHICH HAD GOTTEN WORSE OVER THE NEXT FEW DAYS. SHE USED BENADRYL CREAM TO GET SOME RELIEF. BY THURSDAY 05/31/18, HER RASH HAD SPREAD AND HER KNEES WERE ALSO SWOLLEN AND FELT WARM. PATIENT CALLED THE DOCTOR AND IS SCHEDULED TO BE SEEN ON 06/01/2018.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Muscle pain on the left arm when raising arm. Other movements do not cause pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, nausea, severe fatigue, muscle aches x 24 hours.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysphagia, Headache, Pharyngeal oedema
Clinical narrative: Patient reported difficulty swallowing, throat swelling, chest tightness, severe headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives to adjacent area. Treated with over the counter MOTRIN and BENADRYL.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Tremor
Clinical narrative: Pain, chills, nausea, tremors.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: PATIENT'S ARM WAS ITCHING AND SHE NOTICED A LARGE RED RASH AROUND INJECTION SITE THAT WAS WARM TO THE TOUCH. THE AREA WAS SWOLLEN AND EVENTUALLY HER ENTIRE ARM SWELLED.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: PATIENT'S ARM WAS ITCHING AND SHE NOTICED A LARGE RED RASH AROUND INJECTION SITE THAT WAS WARM TO THE TOUCH. THE AREA WAS SWOLLEN AND EVENTUALLY HER ENTIRE ARM SWELLED.
Age: 65.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Gait inability
Clinical narrative: I had 2 vaccines the same day. Hepatitis A and the new Shingles vaccine. Everything was fine until I woke the next day and couldn't walk. Severe pain in my left ankle and it felt like my metatarsals were about to snap in half. Hobbled about with extreme joint pains, in many joints. The left ankle was the worst. I have had arthritic pain in many joints but never in my ankles.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concurrent medical conditions included tingling (in the head and face started on 15th May 2018). On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and papular rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles and papular rash were unknown. The reporter considered the shingles and papular rash to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient did not mention about tingling in the head and face when she received the SHINGRIX. She filled out that she was feeling well. On 19th May 2018, the patient went back to the pharmacy and stated that she had shingles (bumps appeared). The pharmacist called the on-call physician who prescribed VALTREX for the patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 9 cm diameter red, firm, warm to touch surrounding injection site 2 days after injection. Headache chills > evening of injection x 24 hrs.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 20th May 2018 10:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced fever, tremor, headache and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, tremor, headache and chills were recovered/resolved. The reporter considered the fever, tremor, headache and chills to be probably related to SHINGRIX. Additional details were provided as follows: About 12 hours after receiving the vaccine, the patient experienced high fever, chills and shaking that lasted 1 to 2 hours. The patient also experienced headache and took a dose of Ibuprofen. The patient's body temperature was recorded as 99.6 degrees F in morning on the day of reporting.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included fluoxetine, Lisinopril, metformin and simvastatin. On 17th May 2018 15:20, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In May 2018, less than a week after receiving SHINGRIX, the patient experienced feels awful. On 17th May 2018, the patient experienced sore throat, headache, injection site pain, chills, general body pain and influenza like illness. On 17th May 2018 22:00, the patient experienced fever. On an unknown date, the outcome of the fever, sore throat, headache, injection site pain, chills, general body pain, influenza like illness and feels awful were recovered/resolved. The reporter considered the fever, headache, injection site pain, chills and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the sore throat, influenza like illness and feels awful to be related to SHINGRIX. Additional details were provided as follows: By 22:00 to 22:30 hours that night, 6 hours and 40 minutes to 7 hours and 10 minutes, after vaccination, the patient experienced fever of 102.4 degree F. Less than a day after vaccination, the patient experienced body aches, injection site pain, headache, sore throat and chills and felt like he had the worst flu he had ever had. The patient had some slight pain at the injection site, but it was not that noticeable. The other symptoms were terrible. Less than a week after vaccination, the patient feels awful. The patient just felt awful for the next few days. On 21st May 2018, the patient was close to normal, so the symptoms had resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included fluoxetine, Lisinopril, metformin and simvastatin. On 17th May 2018 15:20, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In May 2018, less than a week after receiving SHINGRIX, the patient experienced feels awful. On 17th May 2018, the patient experienced sore throat, headache, injection site pain, chills, general body pain and influenza like illness. On 17th May 2018 22:00, the patient experienced fever. On an unknown date, the outcome of the fever, sore throat, headache, injection site pain, chills, general body pain, influenza like illness and feels awful were recovered/resolved. The reporter considered the fever, headache, injection site pain, chills and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the sore throat, influenza like illness and feels awful to be related to SHINGRIX. Additional details were provided as follows: By 22:00 to 22:30 hours that night, 6 hours and 40 minutes to 7 hours and 10 minutes, after vaccination, the patient experienced fever of 102.4 degree F. Less than a day after vaccination, the patient experienced body aches, injection site pain, headache, sore throat and chills and felt like he had the worst flu he had ever had. The patient had some slight pain at the injection site, but it was not that noticeable. The other symptoms were terrible. Less than a week after vaccination, the patient feels awful. The patient just felt awful for the next few days. On 21st May 2018, the patient was close to normal, so the symptoms had resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Full blood count normal, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX (batch number D3L5G ?, expiry date 29th November 2020 GSK note: the reported lot number did not match with any GSK lot number). The patient's past medical history included varicella (Dermant Chiken pox in the past). Concomitant products included BYSTOLIC and lamotrigine. On 15th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills and fever. On 20th May 2018, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a mild rash on her arm that is pinkish in color and the rash appeared in four spots near the injection site on her arm. The red spot or rash increased this morning. The patient's body temperature was recorded as 100.5 degree F. The patient experienced fever and chills last week. The patient had CDC done which came back in the normal range. The dermatologist wanted to start her regimen of VALTREX which she planned on starting today. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of numbness of upper extremities in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were unknown. The reporter considered the numbness of upper extremities and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing whole arm numbness and tingling. No other specifics were known at the time of reporting. This reporter stated another person would also be reporting as she in the same meeting today, which had not been done by the time of this report completion.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 79-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). Concomitant products included Levothyroxine, Metformin, omeprazole, Atorvastatin, carvedilol, citalopram, hydrochlorothiazide and lisinopril. On 9th May 2018, 11:14, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced diarrhea, vomiting and nausea. On an unknown date, the outcome of the diarrhea, vomiting and nausea were recovered/resolved. The reporter considered the diarrhea, vomiting and nausea to be unrelated to SHINGIRX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient claimed that she experienced diarrhea, nausea and vomiting for one week after receiving the SHINGRIX vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Skin tightness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 18th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and skin tightness. On an unknown date, the outcome of the injection site erythema, injection  site warmth and skin tightness were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and skin tightness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced tightness at injection site. The events were slowly spreading downwards towards the elbow. The patient was still experiencing these reactions at the time of reporting. No additional information was provided.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child c/o swelling w/redness on R/A. Arm felt hot by touch. Advised mom to rest in ice. Vaccine PROQUAD R/A.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of general body pain in a female patient who received SHINGRIX. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, several hours after receiving SHINGRIX, the patient experienced general body pain and fever. On 21st May 2018, the outcome of the general body pain and fever were recovered/resolved. The reporter considered the general body pain and fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported, however patient was in the mid 50s. The patient received the vaccine during the day and developed severe body aches and fever that night. The patient's body temperature was recorded as 104 degree F over the weekend. The patient could not do anything over the weekend (incapacitated). The effects resolved in 3 to 4 days. This case was linked to the case US2018091579, reported by the same reporter for the husband.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of general body pain in a 50-year-old male patient who received SHINGRIX. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain and fever. On 21st May 2018, the outcome of the general body pain and fever were recovered/resolved. The reporter considered the general body pain and fever to be probably related to SHINGRIX. Additional details were provided as follows: The patient was in the mid 50s and received the vaccine during the day and developed severe body aches and fever that night. The fever was 104 degrees F over the weekend. The patient could not do anything over the weekend. The effects resolved in 3 to 4 days. This case has been linked to case US2018091576, reported by same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of explosive diarrhea in a 80-year-old female patient who received SHINGRIX. Concurrent medical conditions included leukemia. Concomitant products included acyclovir, Albuterol, Losartan, EVISTA, IMBRUVICA, PULMICORT, Diphenoxylate HCL and Atropine Sulfate, IMODIUM, SOLU-CORTEF, terazosin, VAGIFEM and VITEYES. On 20th May 2018, the patient received the 1st dose of SHINGRIX. On 20th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced explosive diarrhea and injection site muscle pain. On an unknown date, the outcome of the explosive diarrhea was recovered/resolved and the outcome of the injection site muscle pain was not recovered/not resolved. The reporter considered the explosive diarrhea to be related to SHINGRIX. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient had a sudden onset of violent diarrhea about 3 hours after receiving SHINGRIX. Her stomach was emptied and the diarrhea resolved. Less than a day after receiving SHINGRIX, the patient also had some muscle pain at the injection site of the vaccine. The reporter denied permission to contact physician.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypersensitivity, Pyrexia, Urticaria
Clinical narrative: 2 hours after vaccination baby developed fever and urticaria of the body allergic reaction.
Age: 17.0
Sex: F
Vaccine: HPV9, HPVX
Symptoms: Amenorrhoea
Clinical narrative: Menstrual periods stopped since HV vaccination #1 in Feb.2018. She had regular periods monthly prior to HPV vaccination.