chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Myalgia, Tremor
Clinical narrative: Starting at midnight 11 hours after receiving immunization patient experienced 4 hours of uncontrollable chills/shaking (6 blankets didn't help), followed by intermittent shaking next 24 hours. Patient experienced grade 3 injection site redness >100mm, pain grade 3 severe lasting 72 hours, myalgia grade 3 prevented ADL 48 hour, fatigue grade 3 prevented ADL 72 hour, malaise grade 3 prevented ADL 72 hours. Patient missed work (RN) due to adverse effects and spent time in bed. Patient return to work 10/6/2020 with mild fatigue, mild injection site redness, mild injection site pain.
Age: 24.0
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Lip swelling, Paraesthesia oral, Urticaria
Clinical narrative: hives left arm 3 minutes after vaccine administration, lip swelling and tingling starting 10 minutes after
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: bump to L arm the swelling runs all the way from the upper arm all the way to the elbow, yesterday pt had some vaccines apply the vaccine apply on the L upper arm was the mcv, ibuprofen was given today in the morning and the medication help, but the arm continues to be swollen .Aunt feels a bump and its really hard and the arm feels really hot .
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Asthenia, Decreased appetite, Dizziness, Dyspnoea, Headache
Clinical narrative: light headedness, dizziness, loss of appetite, headache, weakness, shortness of breath.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Balance disorder, Decreased appetite, Diarrhoea, Dizziness, Gait disturbance
Clinical narrative: light headedness, dizziness, loss of appetite, headache, weakness, shortness of breath.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Hypertensive crisis, Vertigo
Clinical narrative: light headedness, dizziness, loss of appetite, headache, weakness, shortness of breath.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Asthenia, Decreased appetite, Dizziness, Dyspnoea, Headache
Clinical narrative: Very light-headed to the point of having vertigo at one time; mild light-headedness still going on (Oct.6). Loss of balance--could not walk straight, often  bumped into walls; this is still going on, but slightly decreased. Diarrhea for three days; Decreased appetite; continuing. Hypertensive  Crisis for three days.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Balance disorder, Decreased appetite, Diarrhoea, Dizziness, Gait disturbance
Clinical narrative: Very light-headed to the point of having vertigo at one time; mild light-headedness still going on (Oct.6). Loss of balance--could not walk straight, often  bumped into walls; this is still going on, but slightly decreased. Diarrhea for three days; Decreased appetite; continuing. Hypertensive  Crisis for three days.
Age: 66.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Hypertensive crisis, Vertigo
Clinical narrative: Very light-headed to the point of having vertigo at one time; mild light-headedness still going on (Oct.6). Loss of balance--could not walk straight, often  bumped into walls; this is still going on, but slightly decreased. Diarrhea for three days; Decreased appetite; continuing. Hypertensive  Crisis for three days.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Paraesthesia oral
Clinical narrative: localized swelling and pruritus at site of injection 10 minutes after injection . She had no difficulty breathing but did experience mild lip tingling several hours later. All symptoms were relieved with Benadryl
Age: 22.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Skin warm
Clinical narrative: Patient developed redness which progressively increased and pain at left arm injection site as well as fevers managed with motrin and Tylenol. Symptoms began a few hours after vaccination earlier that day on 10/2/2020 Patient seeked medical care at ED on 10/4 evening due to worsening redness, warmth, pain and fevers.  Findings concerning for cellulitis of left arm and patient was started on IV antibiotics in the ED, which was transitioned to narrowed spectrum and then oral antibiotics on 10/6 due to significant improval of symptoms.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Leg became red, swollen, with hives all around injection site and outward.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: rash, 'hives'
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, hot to touch at injection site of left arm
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Swollen tongue
Clinical narrative: Patient said he had swollen tongue at night around 8 pm the day he took his flu vaccine, he didn't take any new medication or ate anything different that he remembers of . He took a Benadryl tablet and swelling went down in about 2 hours , he didn't contact his doctor or pharmacy
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Nervousness, Palpitations, Paraesthesia, Skin tightness
Clinical narrative: At 12 :40. when driving home after the flu shot, patient started to feel face tingle and feel tight. Heart was racing, she called her mom on her cell phone because she felt nervous. Went to her home and took Benadryl po 25 mg at 1 10 pm , and then drove to pick up son at daycare. At 545 pm and again at 11:05 pm took 25 mg po . Patient did call her primary physician, and they agreed with her treatment plan. Patient does not like to take medications, so she took the lower dose.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Immediate post-injection reaction, Palpitations
Clinical narrative: Patient was given a flu shot and had immediate reaction in which she was red and splotchy and complained of shortness of breath and just an overall odd feeling. she was given 25 mg of diphenhydramine which she had difficulty taking and continued to have problems with breathing and speaking clearly.  Gave a dose of epinephrine while phoning 911. By the time EMS arrived, pts initial symptoms were almost resolved but now with racing heart beat. Was monitored by ems and then taken to the hospital for observation
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Speech disorder
Clinical narrative: Patient was given a flu shot and had immediate reaction in which she was red and splotchy and complained of shortness of breath and just an overall odd feeling. she was given 25 mg of diphenhydramine which she had difficulty taking and continued to have problems with breathing and speaking clearly.  Gave a dose of epinephrine while phoning 911. By the time EMS arrived, pts initial symptoms were almost resolved but now with racing heart beat. Was monitored by ems and then taken to the hospital for observation
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, tenderness and swelling from the Fluzone injection site traveling down her arm toward her inner arm
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling face
Clinical narrative: PT STATED SHE EXPERIENCE FACIAL SWELLING BUT DID NOT AFFECT BREATHING
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: PATIENT REPORTS FATIGUE AND MUSCLE ACHES WHICH LASTED APPROXIMATELY 32 HOURS; PATIENTS DENIES TAKING ANY OTC PAIN MEDICATION
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: 0300 10/6/2020 woke with high grade fever (102.4), muscle and body aches, chills. Fever responsive to ibuprofen 600 mg.  Fever returned 3 hours after ibuprofen dose. Continuing to have fevers, alternating between acetaminophen and ibuprofen q4h.   Pt does have hx of reacting similarly to flu vaccine on the past, but this year is especially severe.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Myalgia
Clinical narrative: Developed a dry cough and tightness in lower lungs around 4.75 hours after vaccine (10/3 around 4:15 PM). Cough stopped around 5:30.  Developed muscle aches and chills around 7:00. Developed shaking with chills at 8:00. Developed fever of 102.7 at 9:30. Shaking with chills, muscle aches, fever, & tightness in lower lungs continued until I fell asleep around midnight. Awoke at 9:00 AM the next morning and all symptoms were gone & have not returned to date: 10/6 (only fatigue). At advice of online PA at Kaiser I isolated beginning on 10/4 and went in for a covid-19 test Monday morning 10/5 at 8:45 AM. Results came back today (10/6) as negative.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: Developed a dry cough and tightness in lower lungs around 4.75 hours after vaccine (10/3 around 4:15 PM). Cough stopped around 5:30.  Developed muscle aches and chills around 7:00. Developed shaking with chills at 8:00. Developed fever of 102.7 at 9:30. Shaking with chills, muscle aches, fever, & tightness in lower lungs continued until I fell asleep around midnight. Awoke at 9:00 AM the next morning and all symptoms were gone & have not returned to date: 10/6 (only fatigue). At advice of online PA at Kaiser I isolated beginning on 10/4 and went in for a covid-19 test Monday morning 10/5 at 8:45 AM. Results came back today (10/6) as negative.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain, Pain in extremity, Rash
Clinical narrative: very painful arm from elbow to shoulder first 30 hours also virus feeling and body ache all over also very drowsy  first 30 hours              took tylenol  on the second and third day arm was still sore but felt better all over .  fourth and fifth day arm muscle sore to touch and skin rash in same area no fever at any time
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: very painful arm from elbow to shoulder first 30 hours also virus feeling and body ache all over also very drowsy  first 30 hours              took tylenol  on the second and third day arm was still sore but felt better all over .  fourth and fifth day arm muscle sore to touch and skin rash in same area no fever at any time
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Mouth breathing, Nausea, Skin warm
Clinical narrative: Immediately after vaccine was administered, patient reported she might have to pass out and felt nauseated. She had to breathe through her mouth and was warm to the touch. She reported not eaten anything in all day. Patient was given water, some sugar sources, and cold paper towels placed on the back of her back. After 10 minutes of staying seated, patient was fine and left the pharmacy with her family member. Patient knows the pharmacy's phone number and was encouraged to contact with any issues and/or questions.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Malaise, Palpitations, Pruritus, Skin warm
Clinical narrative: On day of vaccination: Heart Palpitation,  malaise, which lasted about 3-4 hours, when patient went to bed at 7pm. Two days later: visible redness about three inches across, one inch high, mild itching. warm to touch. Resolving redness, itching continues,
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Bloody stool and subsequent PCR on stool positive for Rotavirus A (stool collected on 10/1/20)
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Have a temperature; Achy / Soreness; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose few months ago for tolerance refer case US2020AMR199029).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown.   It was unknown if the reporter considered the fever, pain and chills to be related to Shingrix.  Additional details were provided  as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient was vaccinated with 2nd dose of Shingrix. After vaccination patient had temperature, achy, chills and soreness. This case was linked with case US2020AMR199029 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199029:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Electromyogram abnormal, Herpes zoster, Injection site pain, Myalgia
Clinical narrative: seropositive rheumatoid arthritis/Rheumatoid Arthritis Multiple Sites; Right ulnar nerve neuropathy; Shingles; Chronic osteoarthritis; Swelling; Myalgia; Neuralgia; cyst in Popliteal fossa; Diffuse Joint Pain (Arthralgia)/ polyarticular pain/worsening joint pain/polyarticular pain; This case was reported by a consumer and described the occurrence of seropositive rheumatoid arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colonic polyp. Concurrent medical conditions included hyperlipidemia and overweight.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced seropositive rheumatoid arthritis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the seropositive rheumatoid arthritis and shingles were unknown.   It was unknown if the reporter considered the seropositive rheumatoid arthritis and shingles to be related to Shingrix.  The initial information received on 29 September 2020, via medical records. As per records dated 12 November 2018, she states that had Shingrix vaccine last week and stated having a shingles breakout on her back, she developed pain in her right shoulder, pain in her knees and lower legs. As per records dated 19 November 2018,she had diffuse Joint Pain (arthralgia's), shoulders, knees, legs comes in with worsening joint pain that has been affecting both her lower extremities and upper extremities. it started suddenly a week ago when she was diagnosed with shingles. These have been the about one to two weeks after she had Shingrix vaccine. It started suddenly a week ago when she diagnosed with shingles. These have been the about one to two weeks at least she had Shingrix vaccine. On 05 December 2018, she had two, cystic areas seen in right popliteal fossa (5.5 x 1.l x 2 cm and 3.7 x 1.2 x 1.6 cm). As per records dated 10 January 2019, she was receiving prednisone 10 mg tablet, Take 30 mg once daily for 7 days, then 25mg once daily for 7 days, then 20mg once daily 7 days, then 10 mg once daily for 7 days. As per records dated 26 February 2019, was receiving prednisone 5 mg tablet, Take 2 tablets daily x 5 days, then 1 tablet daily x 10 days during 15 February 2019 till 26 February 2019. As per records dated 24 October 2019, she follow up with rheumatologist every weeks. Rheumatoid arthritis multiple sites. On February 2019, EMG (Electromyography) performed, showed mildly abnormal. Mild median nerve neuropathy. Right ulnar nerve neuropathy. As per records dated 07 July 2020, she reported sudden onset polyarticular pain and swelling and myalgias after receiving the Shingrix vaccine to right arm. (wrists, right shoulders both knees) and swelling and myalgia's after receiving the Shingrix vaccine, she saw her PCP who started her on Prednisone taper and Gabapentin for neuralgia reportedly did not help.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Neuropathy peripheral, Pain in extremity, Rheumatoid arthritis, Swelling
Clinical narrative: seropositive rheumatoid arthritis/Rheumatoid Arthritis Multiple Sites; Right ulnar nerve neuropathy; Shingles; Chronic osteoarthritis; Swelling; Myalgia; Neuralgia; cyst in Popliteal fossa; Diffuse Joint Pain (Arthralgia)/ polyarticular pain/worsening joint pain/polyarticular pain; This case was reported by a consumer and described the occurrence of seropositive rheumatoid arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colonic polyp. Concurrent medical conditions included hyperlipidemia and overweight.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced seropositive rheumatoid arthritis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the seropositive rheumatoid arthritis and shingles were unknown.   It was unknown if the reporter considered the seropositive rheumatoid arthritis and shingles to be related to Shingrix.  The initial information received on 29 September 2020, via medical records. As per records dated 12 November 2018, she states that had Shingrix vaccine last week and stated having a shingles breakout on her back, she developed pain in her right shoulder, pain in her knees and lower legs. As per records dated 19 November 2018,she had diffuse Joint Pain (arthralgia's), shoulders, knees, legs comes in with worsening joint pain that has been affecting both her lower extremities and upper extremities. it started suddenly a week ago when she was diagnosed with shingles. These have been the about one to two weeks after she had Shingrix vaccine. It started suddenly a week ago when she diagnosed with shingles. These have been the about one to two weeks at least she had Shingrix vaccine. On 05 December 2018, she had two, cystic areas seen in right popliteal fossa (5.5 x 1.l x 2 cm and 3.7 x 1.2 x 1.6 cm). As per records dated 10 January 2019, she was receiving prednisone 10 mg tablet, Take 30 mg once daily for 7 days, then 25mg once daily for 7 days, then 20mg once daily 7 days, then 10 mg once daily for 7 days. As per records dated 26 February 2019, was receiving prednisone 5 mg tablet, Take 2 tablets daily x 5 days, then 1 tablet daily x 10 days during 15 February 2019 till 26 February 2019. As per records dated 24 October 2019, she follow up with rheumatologist every weeks. Rheumatoid arthritis multiple sites. On February 2019, EMG (Electromyography) performed, showed mildly abnormal. Mild median nerve neuropathy. Right ulnar nerve neuropathy. As per records dated 07 July 2020, she reported sudden onset polyarticular pain and swelling and myalgias after receiving the Shingrix vaccine to right arm. (wrists, right shoulders both knees) and swelling and myalgia's after receiving the Shingrix vaccine, she saw her PCP who started her on Prednisone taper and Gabapentin for neuralgia reportedly did not help.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Synovial cyst
Clinical narrative: seropositive rheumatoid arthritis/Rheumatoid Arthritis Multiple Sites; Right ulnar nerve neuropathy; Shingles; Chronic osteoarthritis; Swelling; Myalgia; Neuralgia; cyst in Popliteal fossa; Diffuse Joint Pain (Arthralgia)/ polyarticular pain/worsening joint pain/polyarticular pain; This case was reported by a consumer and described the occurrence of seropositive rheumatoid arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colonic polyp. Concurrent medical conditions included hyperlipidemia and overweight.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced seropositive rheumatoid arthritis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the seropositive rheumatoid arthritis and shingles were unknown.   It was unknown if the reporter considered the seropositive rheumatoid arthritis and shingles to be related to Shingrix.  The initial information received on 29 September 2020, via medical records. As per records dated 12 November 2018, she states that had Shingrix vaccine last week and stated having a shingles breakout on her back, she developed pain in her right shoulder, pain in her knees and lower legs. As per records dated 19 November 2018,she had diffuse Joint Pain (arthralgia's), shoulders, knees, legs comes in with worsening joint pain that has been affecting both her lower extremities and upper extremities. it started suddenly a week ago when she was diagnosed with shingles. These have been the about one to two weeks after she had Shingrix vaccine. It started suddenly a week ago when she diagnosed with shingles. These have been the about one to two weeks at least she had Shingrix vaccine. On 05 December 2018, she had two, cystic areas seen in right popliteal fossa (5.5 x 1.l x 2 cm and 3.7 x 1.2 x 1.6 cm). As per records dated 10 January 2019, she was receiving prednisone 10 mg tablet, Take 30 mg once daily for 7 days, then 25mg once daily for 7 days, then 20mg once daily 7 days, then 10 mg once daily for 7 days. As per records dated 26 February 2019, was receiving prednisone 5 mg tablet, Take 2 tablets daily x 5 days, then 1 tablet daily x 10 days during 15 February 2019 till 26 February 2019. As per records dated 24 October 2019, she follow up with rheumatologist every weeks. Rheumatoid arthritis multiple sites. On February 2019, EMG (Electromyography) performed, showed mildly abnormal. Mild median nerve neuropathy. Right ulnar nerve neuropathy. As per records dated 07 July 2020, she reported sudden onset polyarticular pain and swelling and myalgias after receiving the Shingrix vaccine to right arm. (wrists, right shoulders both knees) and swelling and myalgia's after receiving the Shingrix vaccine, she saw her PCP who started her on Prednisone taper and Gabapentin for neuralgia reportedly did not help.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Groin pain, Herpes zoster, Hypoaesthesia, Impaired gastric emptying
Clinical narrative: postherpetic neuralgia; shingles; Myalgia; nerve pain; chronic pelvic floor pain/pelvis aches; bilateral numbness in legs; Pudendal neuralgia/pudenda I nerve block; Chronic pain syndrome; hip ache; This case was reported by a lawyer and described the occurrence of post herpetic neuralgia in a patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced post herpetic neuralgia and shingles. On an unknown date, the outcome of the post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the post herpetic neuralgia and shingles to be related to SHINGRIX.  The initial information received on 29 September 2020 via medical records. As per the pharmacy records on 04 August 2018, she had SHINGRIX, 0.5 ml, intramuscular injection. As per the records dated 18 January 2020, Patient states that she started (Physical therapy) PT in July 2018. Patient stated that she had pudendal nerve pain. Patient stated that she tried to return to PT but she got shingles 3x. Patient stated that she was hospitalized with the shingles and was discharged to PT due to medical complications. On 05 November 2018, she had past medical history significant for gastroparesis who presents with severe pain of the right hip and leg region which started shortly after bilateral obturator injections for pelvic pain, in preparation for pelvic rehab. The patient states when she woke up from the procedure, she had bilateral numbness in the legs. The left leg normalized within several hours; however, the right leg took longer to normalize. Once the numbness went away, she experienced burning, aching pain in the right groin region. She outlines an area that is similar in distribution to the L 1 dermatome. She also notes pain in the right buttock region. The pain at times will go down the back of her thigh ending above the knee. She describes it as burning. 28 November 2018 There is mild osteoarthritis of the hips. As per records dated 07 April 2020, she had PudendaI neuralgia since 04 March 2020. She had Patient had 100 percent relief with both the right pudendal nerve block and posterior femoral cutaneous nerve block.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nerve block, Neuralgia, Osteoarthritis, Pain
Clinical narrative: postherpetic neuralgia; shingles; Myalgia; nerve pain; chronic pelvic floor pain/pelvis aches; bilateral numbness in legs; Pudendal neuralgia/pudenda I nerve block; Chronic pain syndrome; hip ache; This case was reported by a lawyer and described the occurrence of post herpetic neuralgia in a patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced post herpetic neuralgia and shingles. On an unknown date, the outcome of the post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the post herpetic neuralgia and shingles to be related to SHINGRIX.  The initial information received on 29 September 2020 via medical records. As per the pharmacy records on 04 August 2018, she had SHINGRIX, 0.5 ml, intramuscular injection. As per the records dated 18 January 2020, Patient states that she started (Physical therapy) PT in July 2018. Patient stated that she had pudendal nerve pain. Patient stated that she tried to return to PT but she got shingles 3x. Patient stated that she was hospitalized with the shingles and was discharged to PT due to medical complications. On 05 November 2018, she had past medical history significant for gastroparesis who presents with severe pain of the right hip and leg region which started shortly after bilateral obturator injections for pelvic pain, in preparation for pelvic rehab. The patient states when she woke up from the procedure, she had bilateral numbness in the legs. The left leg normalized within several hours; however, the right leg took longer to normalize. Once the numbness went away, she experienced burning, aching pain in the right groin region. She outlines an area that is similar in distribution to the L 1 dermatome. She also notes pain in the right buttock region. The pain at times will go down the back of her thigh ending above the knee. She describes it as burning. 28 November 2018 There is mild osteoarthritis of the hips. As per records dated 07 April 2020, she had PudendaI neuralgia since 04 March 2020. She had Patient had 100 percent relief with both the right pudendal nerve block and posterior femoral cutaneous nerve block.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pelvic pain, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Myalgia; nerve pain; chronic pelvic floor pain/pelvis aches; bilateral numbness in legs; Pudendal neuralgia/pudenda I nerve block; Chronic pain syndrome; hip ache; This case was reported by a lawyer and described the occurrence of post herpetic neuralgia in a patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced post herpetic neuralgia and shingles. On an unknown date, the outcome of the post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the post herpetic neuralgia and shingles to be related to SHINGRIX.  The initial information received on 29 September 2020 via medical records. As per the pharmacy records on 04 August 2018, she had SHINGRIX, 0.5 ml, intramuscular injection. As per the records dated 18 January 2020, Patient states that she started (Physical therapy) PT in July 2018. Patient stated that she had pudendal nerve pain. Patient stated that she tried to return to PT but she got shingles 3x. Patient stated that she was hospitalized with the shingles and was discharged to PT due to medical complications. On 05 November 2018, she had past medical history significant for gastroparesis who presents with severe pain of the right hip and leg region which started shortly after bilateral obturator injections for pelvic pain, in preparation for pelvic rehab. The patient states when she woke up from the procedure, she had bilateral numbness in the legs. The left leg normalized within several hours; however, the right leg took longer to normalize. Once the numbness went away, she experienced burning, aching pain in the right groin region. She outlines an area that is similar in distribution to the L 1 dermatome. She also notes pain in the right buttock region. The pain at times will go down the back of her thigh ending above the knee. She describes it as burning. 28 November 2018 There is mild osteoarthritis of the hips. As per records dated 07 April 2020, she had PudendaI neuralgia since 04 March 2020. She had Patient had 100 percent relief with both the right pudendal nerve block and posterior femoral cutaneous nerve block.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Joint warmth, Musculoskeletal stiffness, Pain
Clinical narrative: Left olecranon bursitis; swelling of left elbow; inflammatory polyarthritis/Inflammatory polyarthritis; seronegative rheumatoid arthritis; Pain; Stiffness; Synovitis present over the wrists right greater than left; This case was reported by a lawyer and described the occurrence of inflammatory polyarthritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inflammatory polyarthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the inflammatory polyarthritis was unknown.   It was unknown if the reporter considered the inflammatory polyarthritis to be related to Shingrix.  The initial information received on 29 September 2020 via medical records. As per the records date 08 April 2018, the male patient had concurrent condition of Hypertriglyceridemia and High density lipoprotein deficiency. As per the pharmacy records dated 29 September 2018, the male patient received SHINGRIX 50 mcg Injection intramuscular. As per the record dated 11 March 2019, he had been off of prednisone for about a week. At that time, he had pain is rated 1 and Stiffness of 5 min. Inflammatory polyarthritis, seronegative rheumatoid arthritis. He was on prednisone 2.5 mg a day and prednisone 5 mg per day. As per the records dated 09 January 2018 he had total knee arthroplasty and on 09 January 2016, he had joint replacement knee surgery. On 07 December 2018, he had Synovitis present over the wrists, right greater than left. On 06 September 2019 he had 1 week of swelling left elbow, causing pain, sore to touch. As per the records dated 12 February 2020, he had mild warmth noted around the left elbow and olecranon bursa.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Polyarthritis, Rheumatoid arthritis, Synovitis, Tenderness
Clinical narrative: Left olecranon bursitis; swelling of left elbow; inflammatory polyarthritis/Inflammatory polyarthritis; seronegative rheumatoid arthritis; Pain; Stiffness; Synovitis present over the wrists right greater than left; This case was reported by a lawyer and described the occurrence of inflammatory polyarthritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inflammatory polyarthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the inflammatory polyarthritis was unknown.   It was unknown if the reporter considered the inflammatory polyarthritis to be related to Shingrix.  The initial information received on 29 September 2020 via medical records. As per the records date 08 April 2018, the male patient had concurrent condition of Hypertriglyceridemia and High density lipoprotein deficiency. As per the pharmacy records dated 29 September 2018, the male patient received SHINGRIX 50 mcg Injection intramuscular. As per the record dated 11 March 2019, he had been off of prednisone for about a week. At that time, he had pain is rated 1 and Stiffness of 5 min. Inflammatory polyarthritis, seronegative rheumatoid arthritis. He was on prednisone 2.5 mg a day and prednisone 5 mg per day. As per the records dated 09 January 2018 he had total knee arthroplasty and on 09 January 2016, he had joint replacement knee surgery. On 07 December 2018, he had Synovitis present over the wrists, right greater than left. On 06 September 2019 he had 1 week of swelling left elbow, causing pain, sore to touch. As per the records dated 12 February 2020, he had mild warmth noted around the left elbow and olecranon bursa.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain, Hypersensitivity, Urticaria
Clinical narrative: allergic reaction / "abdominal allergic" reaction; bloating; abdominal pain; I also had hives break out on my arms; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 23-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Concurrent medical conditions included alpha gal allergy and allergic to mammal products..   On 17th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 17th September 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced allergic reaction, bloating, abdominal pain and urticaria. The patient was treated with benadryl (nos) (Benadryl). On 17th September 2020, the outcome of the urticaria was recovered/resolved. On 20th September 2020, the outcome of the allergic reaction, bloating and abdominal pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, bloating, abdominal pain and urticaria to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval quadrivalent and she experienced allergic reaction, abdominal allergic reaction, bloating, abdominal pain and hives break out of her arms. The abdominal pain and bloating lasted three days which is pretty normal and the hives resolved later that day after taking Benadryl. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Swelling on neck was hard / swelling size of a large jelly bean and than to a size if thumb in lenght; Neck that was really sore and tender; swollen node moved or another node has become swollen that is located near jawbone or ear; Injection hurt pretty bad; aches/ Body aches and pain; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included breast cancer and fibromyalgia.   On 16th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). In September 2020, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On 16th September 2020, the patient experienced injection site pain and general body pain. On 23rd September 2020, the patient experienced neck swelling, neck pain and enlargement of lymph nodes. The action taken with Influenza vaccine Quadrivalent 2020-2021 season was unknown. On 20th September 2020, the outcome of the injection site pain, general body pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the neck swelling and neck pain were not recovered/not resolved and the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the injection site pain, general body pain, pain in arm, neck swelling, neck pain and enlargement of lymph nodes to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient's medical history included breast cancer. The patient received 1st dose of Shingrix and an unknown name of the high dose flu shot for seniors for both on left arm. Due to history of breast cancer, it was advised not to receive vaccines on right arm. The patient reported the injection hurt pretty bad and that began to ache that evening, but woke up the next day with severe aches. The patient believed severity might also been attributed to fibromyalgia. The body aches and pain and sore arm completely resolved on 20th September 2020. 7 days after vaccination, there was swelling on left side of neck that was really sore and tender. The patient reported that swelling started off as the size of a larger jelly bean and then expanded to the size of a thumb in length. Initially the swelling on neck was hard but now it had reportedly gotten softer. The patient suspects that the swollen node moved or another node became swollen that was located near jawbone or ear. The patient was concerned due to history od breast cancer and the involvement of two lymph nodes on arm during that battle. The patient reported never developed a fever and not felt bad. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Chills, Injection site pain, Lymphadenopathy, Nausea, Oral candidiasis
Clinical narrative: she is getting thrush in her mouth; her left arm was sore (at the injection site); nausea; her left armpit lymph nodes were swollen; shivering; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) (batch number 276570, expiry date 30th June 2021) for prophylaxis.   On 25th September 2020 17:00, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2020, the patient received FLUCELVAX QUADRIVALENT (intramuscular). In September 2020, 9 hrs after receiving Shingrix, the patient experienced injection site pain, nausea, enlargement of lymph nodes and shivering. On 28th September 2020, the patient experienced oral thrush. The action taken with FLUCELVAX QUADRIVALENT was unknown. On an unknown date, the outcome of the injection site pain and enlargement of lymph nodes were recovering/resolving and the outcome of the nausea was unknown and the outcome of the shivering was recovered/resolved and the outcome of the oral thrush was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, enlargement of lymph nodes, shivering and oral thrush to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix intramuscularly on left deltoid. The patient also received Flucelvax quadrivalent shot intramuscularly on right deltoid at the same visit. The patient had the lot number and expiry date for the flu shot but not for the Shingrix. Around 02:00 on 26th September 2020, the patient woke up with nausea and left arm was sore at the injection site and left armpit lymph nodes were swollen also was shivering. The patient stayed in bed on 26th september 2020. On 27th September 2020, felt better and got up and did some things. On 28th September 2020, was nauseated again and said it look like was getting thrush in mouth. The injection site soreness was still sore but was about 75 percent better. The lymph node swelling had gone down but was still touchy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: PHN symptoms have "gotten worse."; PHN symptoms have "gotten worse."; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced post herpetic neuralgia and condition aggravated. On an unknown date, the outcome of the post herpetic neuralgia and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the post herpetic neuralgia and condition aggravated to be related to Shingrix.  Additional details were reported as follows: Thew age at vaccination was not reported. The patient had a medical history of shingles and post herpetic neuralgia (PHN). The patient stated that 2 to 3 months before reporting received 1st dose of Shingrix. The stated that 1 month ago her Post Herpetic Neuralgia symptoms had gotten worse. The reporter did not consent to follow up. The reporter did not had any other information for this adverse event.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Skin discolouration
Clinical narrative: where she received the injection was black and blue; This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a 53-year-old female patient who received SHINGRIX for prophylaxis.   On 6th January 2020, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 9 months after receiving SHINGRIX, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX.  Additional details were provided as follows: The patient had reported the event for herself. The patient received 1st dose, she could not remember which arm. The reporter mentoned that, her arm where she received the injection was black and blue but she had no discomfort from the second injection. The permission to follow-up was denied. This case had been linked with US2020AMR197100 and US2020AMR197099, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197100:same reporter US-GLAXOSMITHKLINE-US2020AMR197099:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first SHINGRIX vaccine 2 years ago; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included Herpes zoster (SHINGRIX) for prophylaxis.   On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and the 2nd dose of SHINGRIX. On 27th August 2020, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On 10th September 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   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 applicable for 2nd dose of SHINGRIX.  Till the time of reporting, patient did not received 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient received 1st dose of SHINGRIX and experienced shingles 5 weeks ago which lasted for 3 weeks. The reporter did not consented to follow up.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature increased, Chills, Dizziness, Muscular weakness, Rhinorrhoea
Clinical narrative: Sudden rise in body temp and onset of uncontrollable shaking (could not hold thermometer in my mouth; had to put thumb and corner of pillow in between my teeth to keep from cracking a tooth). Managed to take 400 mg ibuprofen and about 75 min later shaking/chills mostly subsided; temp at that time was 100 degrees. Normal temp 97.3 - about 12 days before temp on waking was back to normal. Weakness in legs and dizziness first 5 days after vaccine. Sinus congestion, runny nose.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: SARS-CoV-2 test negative, Sinus congestion, Tremor
Clinical narrative: Sudden rise in body temp and onset of uncontrollable shaking (could not hold thermometer in my mouth; had to put thumb and corner of pillow in between my teeth to keep from cracking a tooth). Managed to take 400 mg ibuprofen and about 75 min later shaking/chills mostly subsided; temp at that time was 100 degrees. Normal temp 97.3 - about 12 days before temp on waking was back to normal. Weakness in legs and dizziness first 5 days after vaccine. Sinus congestion, runny nose.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Vaccine placed on the outer arm. Redness and swelling noted approximately 2.5 x 2 inches in size. . Employee complains of pain and burning in the affected area.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain, Rash, Rash erythematous, Rash papular
Clinical narrative: 9/1/2020 - Pt receives Shingrix Dose #1 9/17/2020 - Burning/pain in Rt Scapular begins 9/22/2020 - Papulo-besicular groupl red hyperesthetic rash left scapula/Left lateral breast
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: 9/1/2020 - Pt receives Shingrix Dose #1 9/17/2020 - Burning/pain in Rt Scapular begins 9/22/2020 - Papulo-besicular groupl red hyperesthetic rash left scapula/Left lateral breast