chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This initial spontaneous report was received from a liability claims examiner at a claims management service and refers to a female patient of unknown age. The patient filed a claim with a pharmacy for injuries/damages from a product supplied to the pharmacy by the company. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. More specifically, on 28-JUN-2018 (reported as the "date of loss"), the patient was vaccinated with PNEUMOVAX 23 at the pharmacy (dose reported as 25mcg/.5; route and lot # not provided). The patient experienced an adverse reaction to the vaccine (not further specified). The outcome of the event was not provided. Causality assessment was considered related. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Lethargy, Pain in extremity
Clinical narrative: Approximately 12 hours after the injection, I developed significant lethargy and chills. I had to leave work about 1 PM as I could not function at work. My teeth were chattering, although I did not feel febrile nor take my body temperature. I slept for about 2 hours when I arrived at home, leaving from work. My left arm was mildly sore and I developed a mild fine pinpoint maculopapular rash about the size of a half-dollar. The next day I felt significantly improved, although not 100%. I was able to return to work the following day. The total duration of this adverse effect, until completely resolved, as 2.5 - 3 days.
Age: 19.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Client stated, after administered Hep A vaccine, client felt dizzy for almost half of the day and a week later after taking 2 capsule of the oral typhoid, client reports hives and itching.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient started off with high fever and a sore arm. On the next day, the fever spiked to 101F. Pt went to see the doctor with a swelling arm. Doctor prescribed antibiotic LEVAQUIN 500mg for her. Since then she felt better and the fever went down.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Pain in right gluteal region started 7/15/18. Worsened Mon 7/16 but patient was able to complete her run. Today (7/17) pain has worsened further, patient had to stop run because of pain. Ibuprofen has helped.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Injection site erythema, Migraine
Clinical narrative: Patient typically suffers from Chronic Migraines despite being on topiramate, IMITREX and receiving BOTOX for migraines. She has migraines around 28 to 29 days per month. On the evening of the SHINGRIX vaccination, patient claims she had the worst migraine she has ever had and felt very lightheaded and dizzy. She said she nearly went to the Emergency room as a result. She also had about 6 inches of redness around the injection site which has subsided since the day of the injection. She has also recovered from the severe migraine/lightheadedness/dizziness and continues to experience regular migraines.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Asthenia, Cold sweat, Cough, Diarrhoea, Dizziness
Clinical narrative: PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Oropharyngeal pain, Photophobia, Pyrexia, Sensation of foreign body, Vomiting
Clinical narrative: PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Gait disturbance, Hypersomnia, Malaise, Meningitis aseptic, Pyrexia
Clinical narrative: PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination complication, Visual impairment
Clinical narrative: PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Rash, Rash vesicular
Clinical narrative: Night of vaccine had bad headache and nausea. Pain in the site. 4 days later had what appears to be shingles rash on back - went to doctor on 7/17/2018 and they said it might be shingles - they were not totally sure - but treating as shingles - providing me with anti-viral medication - will start the medication today - so still have symptoms at time of filling out form.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Diffuse rash and fever up to 102.2.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Injection site pain, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Less than 24h after vaccination, patient experienced progressive swelling, induration, red blotchy rash, and pain at R upper extremity around injection side. Swelling and pain continued down arm, with sensation of swelling and pain into hand and into the R neck.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Rash erythematous, Rash macular, Swelling
Clinical narrative: Less than 24h after vaccination, patient experienced progressive swelling, induration, red blotchy rash, and pain at R upper extremity around injection side. Swelling and pain continued down arm, with sensation of swelling and pain into hand and into the R neck.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Peripheral swelling, Rash
Clinical narrative: Swelling, rash and discomfort of arm. This was reported by the patient to the clinic's customer service line. She did not come to the clinic for an exam. On further follow-up she states that she is doing better but not completely resolved.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: 15-20 seconds after vaccine administration pt. stated he wanted to sit for a few minutes. He then said he felt light headed, became pale and his head tipped back against the wall. Pt. loss consciousness,and exhibited seizure activity., 2 other RNs responded 911 initiated and pt. lowered to floor by 2 nurses. Pt. regained consciousness. pt. was diaphoretic and pale, BP was 122/72, and pulse was 56. Pt. transported via Search and Rescue to hospital ER which is in the same building as Public Health. Pt. did have emesis when on stretcher and declined Search and Rescue IV placement. Pt. gave permission for his Mother to be called which PH did.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Seizure, Vomiting
Clinical narrative: 15-20 seconds after vaccine administration pt. stated he wanted to sit for a few minutes. He then said he felt light headed, became pale and his head tipped back against the wall. Pt. loss consciousness,and exhibited seizure activity., 2 other RNs responded 911 initiated and pt. lowered to floor by 2 nurses. Pt. regained consciousness. pt. was diaphoretic and pale, BP was 122/72, and pulse was 56. Pt. transported via Search and Rescue to hospital ER which is in the same building as Public Health. Pt. did have emesis when on stretcher and declined Search and Rescue IV placement. Pt. gave permission for his Mother to be called which PH did.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Crying, Erythema, Immediate post-injection reaction, Induration, Pain
Clinical narrative: Pt began crying in pain immediately after IZ given and had localized swelling, erythema, and indurated center; no anaphylaxis. Immediately gave BENADRYL 7 ml one-time and took set of repeat vitals; vital signs stable and w/in 10 min of BENADRYL administration, swelling came down. Pt remained in office another 15 minutes w/o further issues.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Swelling
Clinical narrative: Pt began crying in pain immediately after IZ given and had localized swelling, erythema, and indurated center; no anaphylaxis. Immediately gave BENADRYL 7 ml one-time and took set of repeat vitals; vital signs stable and w/in 10 min of BENADRYL administration, swelling came down. Pt remained in office another 15 minutes w/o further issues.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Full blood count, Pruritus
Clinical narrative: Pt with cellulitis and extensive reaction at vaccine site. Mild itching, no pain, no fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Red blood cell sedimentation rate, Vaccination site cellulitis, Vaccination site reaction
Clinical narrative: Pt with cellulitis and extensive reaction at vaccine site. Mild itching, no pain, no fever.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Malaise, Nausea, Pallor
Clinical narrative: PATIENT BECAME ILL AFTER VACCINATION, DID NOT LOSE CONSCIOUSNESS BUT FELT VERY FAINT, BROKE OUT IN SWEAT, COLOR WAS POOR, NAUSEATED/VOMITED. MOTHER STATED THAT CHILD ALWAYS FAINTS AFTER INJECTIONS. PATIENT WAS TREATED WITH COLD PACK, WET CLOTHS, LOLLIPOP, SMALL AMOUNT OF COKE OVER ICE; MOTHER ASSISTED WITH TREATMENT. AT NO TIME DID PATIENT FALL OR EXPERIENCE INJURY. PATIENT WAS ASSISTED TO FLOOR TO REST AND RECUPERATE. PATIENT AND MOTHER STATED AT 11:50 THAT HE HAD RECOVERED, AND PATIENT WALKED UNASSISTED THROUGH BUILDING AND OUT TO VEHICLE.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: PATIENT BECAME ILL AFTER VACCINATION, DID NOT LOSE CONSCIOUSNESS BUT FELT VERY FAINT, BROKE OUT IN SWEAT, COLOR WAS POOR, NAUSEATED/VOMITED. MOTHER STATED THAT CHILD ALWAYS FAINTS AFTER INJECTIONS. PATIENT WAS TREATED WITH COLD PACK, WET CLOTHS, LOLLIPOP, SMALL AMOUNT OF COKE OVER ICE; MOTHER ASSISTED WITH TREATMENT. AT NO TIME DID PATIENT FALL OR EXPERIENCE INJURY. PATIENT WAS ASSISTED TO FLOOR TO REST AND RECUPERATE. PATIENT AND MOTHER STATED AT 11:50 THAT HE HAD RECOVERED, AND PATIENT WALKED UNASSISTED THROUGH BUILDING AND OUT TO VEHICLE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Mother reports that patient had vomiting with lunch 1-2 hours after receiving vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported to agent that this patient experienced pain at the injection site following the first dose of SHINGRIX. The event resolved within 3 to 4 days. The patient was expressing reluctance to get the second dose based on this experience. The health care professional did not provide the agent with any further details.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included LIPITOR. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever and cold sweat. On 11th May 2018, the outcome of the fever and cold sweat were recovered/resolved. It was unknown if the reporter considered the fever and cold sweat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown arm. The patient reported that later in night, on the same day of vaccination at 23:00 hours, she experienced a fever and broke out into a cold sweat. The patient stated that she used cool washcloths to cool her self down and by the next morning she felt fine and the symptoms had resolved. The patient stated that the symptoms lasted approximately from 23:00 hours to 06:00 hours. The patient had denied permission to contact their physician.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Injection site pain, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a 77-year-old female patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. Concomitant products included Aspirin, atenolol, CITRACAL, Coq10, fish oil and lisinopril. On 11th September 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season (intramuscular). On 11th September 2017, less than a day after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced injection site pain. On 12th September 2017, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant) and weakness in extremity. On an unknown date, the outcome of the Guillain Barre syndrome, injection site pain and weakness in extremity were recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome, injection site pain and weakness in extremity to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The patient's concomitant medication included CENTRUM SILVER. The patient reported that 1 day after vaccination, she experienced weakness in her legs and arms and low grade Guillain Barre Syndrome. The patient reported that she was evaluated by her physician.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site warmth, Joint stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in thumb in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 30th November 2018) for prophylaxis. On 21st June 2018, the patient received SHINGRIX. On 21st June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site warmth. On 3rd July 2018, the patient experienced pain in thumb, knee pain, tingling of extremity and stiff joint. The patient was treated with prednisone. On an unknown date, the outcome of the pain in thumb, injection site pain, knee pain, injection site warmth, tingling of extremity and stiff joint were unknown. It was unknown if the reporter considered the pain in thumb, injection site pain, knee pain, injection site warmth, tingling of extremity and stiff joint to be related to SHINGRIX. Additional details were received as follows: The patient reported that she experienced injection site pain on the day of the SHINGRIX vaccination. The patient also reported that the injection site was felt warm. The patient began to experience left thumb pain in the injected arm. The patient also reported that some joint pain in the hand as well. She reported that her left knee had an ache behind the knee. The patient also reported some tingling in the left hand. The patient saw her rheumatologist, who prescribed low dose of prednisone.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in thumb in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 30th November 2018) for prophylaxis. On 21st June 2018, the patient received SHINGRIX. On 21st June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site warmth. On 3rd July 2018, the patient experienced pain in thumb, knee pain, tingling of extremity and stiff joint. The patient was treated with prednisone. On an unknown date, the outcome of the pain in thumb, injection site pain, knee pain, injection site warmth, tingling of extremity and stiff joint were unknown. It was unknown if the reporter considered the pain in thumb, injection site pain, knee pain, injection site warmth, tingling of extremity and stiff joint to be related to SHINGRIX. Additional details were received as follows: The patient reported that she experienced injection site pain on the day of the SHINGRIX vaccination. The patient also reported that the injection site was felt warm. The patient began to experience left thumb pain in the injected arm. The patient also reported that some joint pain in the hand as well. She reported that her left knee had an ache behind the knee. The patient also reported some tingling in the left hand. The patient saw her rheumatologist, who prescribed low dose of prednisone.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADACEL for prophylaxis. In June 2018, the patient received SHINGRIX and ADACEL. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced weakness of arms, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the weakness of arms, injected limb mobility decreased and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The physician reported that the patient received SHINGRIX and ADACEL in the same arm a month ago. The patient was complaining about her arm was felt weak and it was still sore 1 month later. The heath care professional (HCP) also reported that she experienced limited range of motion and decreased strength in injected arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 67-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 6th July 2018, the patient received SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the headache and nausea to be related to SHINGRIX. Additional details were received as follows: This case was previously not reported anyone. The pharmacist reported that the patient received a dose of SHINGRIX and began to experience nausea and headache, which began approximately 24 hours after the vaccination. At the time of reporting, the symptoms were unresolved.
Sex: F
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that patient had a severe reaction with Hepatitis B vaccine. The HCP was not sure about the manufacturer of the vaccine and did not know what type of reaction the patient had. The HCP did not have any information as a note was left for her from one of her colleagues.
Sex: U
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced weakness of arms and pain in arm. On an unknown date, the outcome of the weakness of arms and pain in arm were recovered/resolved. It was unknown if the reporter considered the weakness of arms and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced arm weakness and soreness for months after receiving a flu vaccine (unsure of brand) in the past. This case has been linked with US2018124862, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, rash, teeth chattering and pain in arm. On an unknown date, the outcome of the fever, rash, teeth chattering and pain in arm were recovered/resolved. The reporter considered the fever, rash, teeth chattering and pain in arm to be probably related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX vaccine between the end of February and 1st March. The patient had a fever of 103 degrees F which lasted for 24 hours. The effects lasted for 3 days. This case was linked with case US2018124952, reported by the same reporter.
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 elderly male patient who received SHINGRIX for prophylaxis. 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 fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient was caller's husband. In 2018, the patient received a dose of SHINGRIX vaccine and had a fever of 100 degrees F. The patient took TYLENOL and fever resolved. This case was linked with US2018124951, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Product availability issue
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of unwell in a adult female 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 and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced unwell, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the unwell was recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional information was received as follows: The age at the 1st dose of SHINGRIX vaccination was not reported. The patient was very upset with vaccine manufacturing company. On the reporting day, the patient annoyed, as she felt very ill for 2 days after the first dose and she had cleared her schedule for 2 days to recover from the second dose, only to find it was not available anywhere in her area. The patient was due for the second dose of SHINGRIX but not one pharmacy in her city where the patient get her medications and they did not know when they would get it. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX due to product availability issue, which led to incomplete course of vaccination. The patient would personally start a class action lawsuit to get her money back and damages if this did not resolve in time for her to get her second dose in the therapeutic window of time recommended. The patient would be interested to know what the manufacturer would recommend to get the 2nd dose in the near future. It occurs to the patient that the responsible thing to do would be to reserve the next batches that manufacturer release for those who had already had the first dose, and were on a deadline to get the second dose. This case has been linked to the case US2018GSK127087 and US2018GSK127086, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Swelling
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain and swelling. On an unknown date, the outcome of the influenza-like symptoms, joint pain and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain and swelling to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient experienced flu-like symptoms for 2 days and had joint soreness and swelling for 5 days post vaccination. The reporter agreed to be followed up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Inappropriate schedule of drug administration, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable nurse. A 6-month-old female patient received two doses of PREVNAR 13, first dose (lot number: S43262, expiration date: 30Sep2018) given on 09Jan2018 at the age of 2 months via intramuscular in the right thigh at 0.5 ml, single and second dose (lot number: T62563, expiration date: 29Feb2020) given on11May2018 at the age of 6 months via an unspecified route of administration in the right thigh at a single dose for routine immunization. Medical history included cough on 28Feb2018 and bronchiolitis and right otitis media; both on unknown dates. Concomitant medications included second dose of PEDIARIX (lot number: 33PA4, expiration date: 24Apr2020), via intramuscular in the left thigh on 09Jan2018 at unknown dose, third dose of ROTATEQ (lot number: N024294, expiration date: 26Feb2019), via oral on unspecified date at unknown dose and first dose of PENTACEL (lot number: C5428AA, expiration date: 09Oct2018), via unspecified route of administration on 11May2018 at unknown dose; all for immunization. The patient previously received first dose of PEDIARIX and first and second doses of ROTATEQ; all for immunization. On 11May2018, the patient experienced inappropriate schedule of vaccine administered as the second dose given at 6 months and 5 days. On 04Jun2018, the patient was congested. It was also reported that the patient was also congested on 14Jun2018. Outcome of the event congested was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Pityriasis
Clinical narrative: Symptoms of pityriasis started showing 7 days after the administation on the left upper torso and hip along with mild flu symptoms.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pain, Rotator cuff syndrome
Clinical narrative: The patient was diagnosed with a rotator cuff injury after receiving the flu shot. He noticed pain immediately after receiving the shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Injection site pain, Insomnia, Nausea
Clinical narrative: Body aches, headache, abdominal pain, nausea, insomnia and nightmares, pain at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nightmare, Pain
Clinical narrative: Body aches, headache, abdominal pain, nausea, insomnia and nightmares, pain at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Pain, Somnolence
Clinical narrative: Mild Flu-like symptoms for 1 day: body aches and weak: slept several hours in afternoon - unusual for me.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: THE AFTERNOON AFTER BEING INJECTED A RED MILDLY RAISED RASH DEVELOPED AROUND INJECTION SITE. 1 12 INCH BY 1 INCH IN SIZE. THE AREA FELT ITCHY. THE PATIENT REPORTED TO THE PHARMACY THE FOLLOWING DAY AND WAS INSTRUCTED TO COVER THE AREA. SHE MAY APPLY VASELINE AND TAKE BENADRYL AS NEEDED FOR ITCHING. IF RASH BECAME WORSE SHE SHOULD CONSULT HER DOCTOR.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt has had increasing redness, swelling, and skin warmth starting a few hours after the vaccination and continuing/worsening overnight.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Biopsy abdominal wall abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Follicle centre lymphoma diffuse small cell lymphoma
Clinical narrative: Pt. developed abdominal pain a few days afterward and ended up in ER with CT abdomen/ pelvis with bulky lymphadenopathy on 6/3/18. Biopsy has confirmed the above findings are consistent Follicle center cell lymphoma. I have no idea if related but feel it is important to report in case a pattern emerges.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Pt. developed abdominal pain a few days afterward and ended up in ER with CT abdomen/ pelvis with bulky lymphadenopathy on 6/3/18. Biopsy has confirmed the above findings are consistent Follicle center cell lymphoma. I have no idea if related but feel it is important to report in case a pattern emerges.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 1ST DOSE OF SHINGRIX GIVEN 5/16/18 AND 2ND DOSE 6/29/18. INTERVAL WAS LESS THAN 2 MONTHS BUT GREATER THAN A MONTH.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain/soreness to touch immediately after injection. The next morning there was significant redness and swelling (area approx. 3 inches across, injection site at the upper area of swelling) occasional burning sensation, pain with touch or movement of arm. ADVIL and icing helped but did not alleviate symptoms. 2nd day was the same. Beginning the 3rd day through the 7th day swelling and redness slowly diminished, but still painful to touch. The 8th day pain is gone, but still slightly discolored.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: Pain/soreness to touch immediately after injection. The next morning there was significant redness and swelling (area approx. 3 inches across, injection site at the upper area of swelling) occasional burning sensation, pain with touch or movement of arm. ADVIL and icing helped but did not alleviate symptoms. 2nd day was the same. Beginning the 3rd day through the 7th day swelling and redness slowly diminished, but still painful to touch. The 8th day pain is gone, but still slightly discolored.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient broke out in rash all over arms and legs after receiving the vaccine. Resolved with time.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER, MUSCLE PAIN SINCE LAST NIGHT.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Raised red itching rash, bilateral on sides of abdomen. Tx hydrocortisone cream to affected area. DEXADRON shot from Doctor, BENADRYL, back again to dr and prescribed prednisone 10 mg x2 for 7 days, then 1 tab each day for 7 days. Starting the Prednisone today, 07/17/2018.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pain, Skin warm, Swelling
Clinical narrative: Large local reaction of erythema, pain, warmth and swelling with body aches and malaise. Severe enough patient required a MD visit and treated with corticosteroids (oral and topical).
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Injection site pruritus, Injection site urticaria, Pain
Clinical narrative: The Tdap was administered first in the left deltoid IM followed by the MENVEO in the same arm IM. The HPV9 was then administered in the right deltoid IM. I then left the room and was called back in approximately 2-3 mins. later by his father who stated he was in pain and appeared to be having a reaction. His left deltoid was covered in solid hives. I got the doctor in there. We got ice, administered BENADRYL, Ibuprofen, Prednisone, TAGAMET, and CLARITIN. His breathing and oxygen saturation remained normal (O2 Sats never below 98%). After about 45 mins. his right deltoid started itching and had a couple of hives. This arm never progressed. Dr. saw this and had me wash his arms off in case this had anything to do with the alcohol used on his skin. After an hour and a half he left feeling tired but much better. I spoke to his father 2 hours later and he stated that his arms were completely normal. Of note, his twin sister had the same vaccines, from the same lot numbers, in the same locations on her arms and did not have any reaction at all. The dad, stated he had not ever had any type of reaction like this before.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Injection site bruising
Clinical narrative: Arm ached and was swollen with bruise at injection site and red in a large oval almost to my elbow: this began within 3 hours from injection and now, 3 days later 7/17, continues to ache, interrupt sleep. Black and blue site and large area of redness continues to be visible and swollen. Within 3 hours of the injection I was extremely fatigued and headache and muscle aches, esp in lower back, no appetite. This continued through 7/16. Took TYLENOL in addition to my usual ibuprofen and slept for 2 days. I remain tired and my arm aches. I called the pharmacist to thank her for warning me I might have side effects. This is the first time I have had a reaction to a shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Arm ached and was swollen with bruise at injection site and red in a large oval almost to my elbow: this began within 3 hours from injection and now, 3 days later 7/17, continues to ache, interrupt sleep. Black and blue site and large area of redness continues to be visible and swollen. Within 3 hours of the injection I was extremely fatigued and headache and muscle aches, esp in lower back, no appetite. This continued through 7/16. Took TYLENOL in addition to my usual ibuprofen and slept for 2 days. I remain tired and my arm aches. I called the pharmacist to thank her for warning me I might have side effects. This is the first time I have had a reaction to a shot.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Blood creatine phosphokinase normal, Blood iron normal, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal
Clinical narrative: I am experiencing muscle spasms, muscle twitching, extreme restlessness, muscle tightening, all over my entire body. All of which began the very next day after I received the Hep A vaccine. My doctor is treating these symptoms with restless leg medication "Pramipexole." It has subdued the symptoms slightly.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Iron binding capacity total normal, Metabolic function test normal, Muscle spasms, Muscle tightness, Muscle twitching
Clinical narrative: I am experiencing muscle spasms, muscle twitching, extreme restlessness, muscle tightening, all over my entire body. All of which began the very next day after I received the Hep A vaccine. My doctor is treating these symptoms with restless leg medication "Pramipexole." It has subdued the symptoms slightly.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Restlessness, Serum ferritin normal, Transferrin saturation
Clinical narrative: I am experiencing muscle spasms, muscle twitching, extreme restlessness, muscle tightening, all over my entire body. All of which began the very next day after I received the Hep A vaccine. My doctor is treating these symptoms with restless leg medication "Pramipexole." It has subdued the symptoms slightly.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chest discomfort, Crying, Gait inability
Clinical narrative: The next day every muscle got hard and cramped. Intense headache, 104-106 temperature, could not walk pain was intense. Pain radiating down arms. Chest muscles so tight it felt like a heart attack. Every muscle and joint so painful. For a 59 year old male to have to stay in bed and just cry from the pain. I needed help even to the bathroom. Never would I ever recommend this to anyone. Very worried whether I'll have side effects.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Loss of personal independence in daily activities, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: The next day every muscle got hard and cramped. Intense headache, 104-106 temperature, could not walk pain was intense. Pain radiating down arms. Chest muscles so tight it felt like a heart attack. Every muscle and joint so painful. For a 59 year old male to have to stay in bed and just cry from the pain. I needed help even to the bathroom. Never would I ever recommend this to anyone. Very worried whether I'll have side effects.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myosclerosis, Pain, Pain in extremity
Clinical narrative: The next day every muscle got hard and cramped. Intense headache, 104-106 temperature, could not walk pain was intense. Pain radiating down arms. Chest muscles so tight it felt like a heart attack. Every muscle and joint so painful. For a 59 year old male to have to stay in bed and just cry from the pain. I needed help even to the bathroom. Never would I ever recommend this to anyone. Very worried whether I'll have side effects.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: KINRIX given instead of DTaP.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Urticaria
Clinical narrative: Patient experienced welts on back and extreme fatigue and weakness the day after.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Chest pain
Clinical narrative: Patient presented to ER with complaints of chest pain. Treatment was IV saline. This is per staff at Hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Ophthalmological examination, Optic ischaemic neuropathy
Clinical narrative: Developed NAION after vaccine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injury corneal, Lacrimation increased, Ocular discomfort, Ocular hyperaemia, Ophthalmological examination abnormal
Clinical narrative: Redness in left eye with tearing and discomfort. Cornea damage appeared 4 - 5 days after redness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, fever feel on skin - 9 hrs - 2 days. Diarrhea 18 hrs later. Joint pain, fatigue next day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: PATIENT CALLED PHARAMCY STATING RASH ALL OVER BODY. TOOK BENADRYL. ADVISED PATIENT TO CONTINUE TAKING BENADRYL AS DIRECTED ON PACKAGING. WILL FOLLOW-UP WITH PATIENT TOMORROW MORNING. DISCUSSED SIGNS/SYMPTOMS IF PATIENT NEEDS TO GO IMMEDIATELY TO THE HOSPITAL.
Age: 74.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Injection site rash, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Patient called on 7/17/18 complained fever (101F) and very tired. She mentioned last night she had soreness on her right arm and rash around the injection site. She also had swollen gland on her right armpit on 7/16/18 night, but not showing on 7/17/18 anymore. I have advised patient to take TYLENOL or ALEVE to reduce fever and see her doctor if necessary.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea, Pallor, Seizure like phenomena
Clinical narrative: After vaccines were administered pt got pale and was about to faint advised pt to lay down pt layed down I went to get water came back gave pt water father stated that when I was getting water Pt had a seizure like symptom when I was back in the room pt was same as when I left just felt nausea.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Haemoglobin normal, Nausea, Pain, Platelet count normal
Clinical narrative: Symptoms: Body aches, chills, fever of 101 degrees, nausea.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: Symptoms: Body aches, chills, fever of 101 degrees, nausea.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Hemiparesis, Injected limb mobility decreased, Injection site swelling, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Swelling in the (R) upper arm cannot move felt stiff, Neck pain with weakness on the (R) side of the body and leg. Called parents to get him from workplace. Went to clinic as advised by Dr. In ER dr advised MOTRIN after seeing him. At 4th day of immunization recovering from his symptoms. Doing better. Still swelling at injection site remains.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Neck pain
Clinical narrative: Swelling in the (R) upper arm cannot move felt stiff, Neck pain with weakness on the (R) side of the body and leg. Called parents to get him from workplace. Went to clinic as advised by Dr. In ER dr advised MOTRIN after seeing him. At 4th day of immunization recovering from his symptoms. Doing better. Still swelling at injection site remains.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient developed fever to 102 degree with redness, warmth at PROQUAD site.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling
Clinical narrative: Swelling purple rash at injection site.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Metabolic function test normal, Pain, Photophobia
Clinical narrative: Has had symptoms off and on since SHINGRIX vax 7.2.18, feeling well at that time. 7/4, see notes, symptoms: severe chills, body aches, fever, emesis, severe HA with photophobia. Resolved after 2 days. On 7/9, recurrent sx, fever, chills, emesis. Better next day. Recurrence early 7/13/18 same sx, started with chills. Each time used ibuprofen or TYLENOL; ibuprofen this morning and usual meds.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Shift to the left, Vomiting, White blood cell count increased
Clinical narrative: Has had symptoms off and on since SHINGRIX vax 7.2.18, feeling well at that time. 7/4, see notes, symptoms: severe chills, body aches, fever, emesis, severe HA with photophobia. Resolved after 2 days. On 7/9, recurrent sx, fever, chills, emesis. Better next day. Recurrence early 7/13/18 same sx, started with chills. Each time used ibuprofen or TYLENOL; ibuprofen this morning and usual meds.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Erythema, Facial pain, Herpes zoster, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. Concomitant products included valaciclovir hydrochloride (Valacyclovir).  On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus. On 5th May 2018, the patient experienced hyperesthesia, feeling irritated, facial swelling and facial pain. In May 2018, the patient experienced shingles. On an unknown date, the outcome of the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain were recovered/resolved. It was unknown if the reporter considered the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient had itching over the right eye on the forehead area. On 5th May 2018, 2 days after vaccination, the patient felt irritated, along with itching, bumps and pain on the right side of the face feeling sensitive. On 8th May 2018, less than a week after vaccination she went to pharmacy notifying them that she has Shingles. On 9th May 2018 at 8:30 AM, she had an appointment with her dermatologist who confirmed that she had Shingles. The itching and irritation lasted for couple weeks. The patient had recovered from the symptoms. The batch number reported 9A539 for SHINGRIX was not found and changed to 9AS39 as per sales data.