chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: THE PATIENT HAD A SWOLLEN ARM WHERE THE VACCINATION WAS INJECTED.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has large, raised and swollen red ring around injection site; says that it sometimes itches; did not occur during first dose in 2-dose series.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Fever, Chills, headache...flu-like symptoms.
Age: 24.0
Sex: F
Vaccine: FLUX, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Hives, rash, red spots on cheeks and stomach.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash papular, Rash vesicular
Clinical narrative: 4 varicella like rash on injection site (R) anterior thigh - treated with mupirocin ointment. Papular-vesicular rash notes 2/24/19, 18 days days after above vaccines were given, as per mom rashes hurt.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Myalgia, Pruritus
Clinical narrative: Muscle pain at injection site radiating across (R) pectoral muscle. Itching across same area as well as in arm pit.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lip swelling, Pain, Swelling face, Swollen tongue
Clinical narrative: Patient came in yesterday (3/14/19) said had reaction to SHINGRIX had normal redness/soreness, but said that she had swelling of lips, tongue and face (not right away) went to Dr. and received steroid shot for it.
Age: 85.0
Sex: F
Vaccine: TD
Symptoms: Dysstasia, Fatigue, Hypoaesthesia, Influenza like illness, Mobility decreased
Clinical narrative: Within 2-3 days felt like flu symptoms started. Weakness in legs, arms and had problems getting up.   One morning woke up and legs felt numb/weak; not sure if could stand up. In January, felt very fatigued; this is out of norm since has high energy. During that period aching at night so took Tylenol very often. Gradually started feeling better by the end of the month. By mid-February felt like had recovered completely. It took about 6 weeks to recover.
Age: 85.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Pain
Clinical narrative: Within 2-3 days felt like flu symptoms started. Weakness in legs, arms and had problems getting up.   One morning woke up and legs felt numb/weak; not sure if could stand up. In January, felt very fatigued; this is out of norm since has high energy. During that period aching at night so took Tylenol very often. Gradually started feeling better by the end of the month. By mid-February felt like had recovered completely. It took about 6 weeks to recover.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Injection into shoulder joint.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Culture positive, Incisional drainage, Injection site discharge, Injection site erythema, Injection site inflammation
Clinical narrative: Patient is a 47-year-old female who is seen for evaluation of right arm injection site reaction. States she had vaccination injections in proximal bilateral upper extremities. States her proximal right upper extremity became raised, red and sore first, and patient had surgery on 11/16/18 by Dr. on injection site of RUE. Patient states her proximal left upper extremity became inflamed after the RUE, and states she had I&D on her left upper extremity injection site on 12/4/18. Patient states the wound on the right upper extremity drained about a month following surgery and stop draining on 1/16/19. States it drained a clear, yellow fluid. Denies any drainage from the wound on the left upper extremity. Per report, cultures revealed Mycobacerium porcinum. Patient sees Dr., and he referred her here for evaluation for possible further debridement. Patient states she has been taking some antibiotics, and after taking these she says her platelet count was low. Patient denies any fever, chills, sweats. Rates pain 1/10. Does report some itching. Ultrasound in office. Follow-up as needed.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Platelet count decreased, Pruritus, Ultrasound scan
Clinical narrative: Patient is a 47-year-old female who is seen for evaluation of right arm injection site reaction. States she had vaccination injections in proximal bilateral upper extremities. States her proximal right upper extremity became raised, red and sore first, and patient had surgery on 11/16/18 by Dr. on injection site of RUE. Patient states her proximal left upper extremity became inflamed after the RUE, and states she had I&D on her left upper extremity injection site on 12/4/18. Patient states the wound on the right upper extremity drained about a month following surgery and stop draining on 1/16/19. States it drained a clear, yellow fluid. Denies any drainage from the wound on the left upper extremity. Per report, cultures revealed Mycobacerium porcinum. Patient sees Dr., and he referred her here for evaluation for possible further debridement. Patient states she has been taking some antibiotics, and after taking these she says her platelet count was low. Patient denies any fever, chills, sweats. Rates pain 1/10. Does report some itching. Ultrasound in office. Follow-up as needed.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dyspnoea, Headache
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Musculoskeletal pain, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood cholesterol increased, Blood triglycerides normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspepsia, Dyspnoea, Electrocardiogram normal, High density lipoprotein normal
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Low density lipoprotein normal, Myalgia, Nausea, Rash, Total cholesterol/HDL ratio normal
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Very low density lipoprotein normal
Clinical narrative: Shaking, chills, rash, tremors, myalgias, arthralgias, nausea, stomach burning, chest pressure, shortness of breath.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Headache, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received SHINGRIX. On 18th February 2019, 1 hr after receiving SHINGRIX, the patient experienced muscle twitching. On 19th February 2019, the patient experienced headache, fatigue, injection site pain, injection site erythema, injection site induration and joint pain. On an unknown date, the outcome of the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching were not reported. It was unknown if the reporter considered the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at around 5:35 PM. About an hour later, there was a rather violent twitching of the muscle at the injection site but the rest of the muscle was relaxed. The patient thought that was odd. On the next day of vaccination, the patient experienced severe joint pain, raging headache, extreme fatigue (on day two and three). The patient also experienced injection site and area about 3 inches diameter, which was hard, intensely red, and very painful, which went through day four (on the date of reporting). The joint pain continued but at a milder level. The above two experienced from day two through day four. The patient had no idea when this would subside.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received SHINGRIX. On 18th February 2019, 1 hr after receiving SHINGRIX, the patient experienced muscle twitching. On 19th February 2019, the patient experienced headache, fatigue, injection site pain, injection site erythema, injection site induration and joint pain. On an unknown date, the outcome of the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching were not reported. It was unknown if the reporter considered the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at around 5:35 PM. About an hour later, there was a rather violent twitching of the muscle at the injection site but the rest of the muscle was relaxed. The patient thought that was odd. On the next day of vaccination, the patient experienced severe joint pain, raging headache, extreme fatigue (on day two and three). The patient also experienced injection site and area about 3 inches diameter, which was hard, intensely red, and very painful, which went through day four (on the date of reporting). The joint pain continued but at a milder level. The above two experienced from day two through day four. The patient had no idea when this would subside.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received SHINGRIX. On 18th February 2019, 1 hr after receiving SHINGRIX, the patient experienced muscle twitching. On 19th February 2019, the patient experienced headache, fatigue, injection site pain, injection site erythema, injection site induration and joint pain. On an unknown date, the outcome of the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching were not reported. It was unknown if the reporter considered the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at around 5:35 PM. About an hour later, there was a rather violent twitching of the muscle at the injection site but the rest of the muscle was relaxed. The patient thought that was odd. On the next day of vaccination, the patient experienced severe joint pain, raging headache, extreme fatigue (on day two and three). The patient also experienced injection site and area about 3 inches diameter, which was hard, intensely red, and very painful, which went through day four (on the date of reporting). The joint pain continued but at a milder level. The above two experienced from day two through day four. The patient had no idea when this would subside.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received SHINGRIX. On 18th February 2019, 1 hr after receiving SHINGRIX, the patient experienced muscle twitching. On 19th February 2019, the patient experienced headache, fatigue, injection site pain, injection site erythema, injection site induration and joint pain. On an unknown date, the outcome of the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching were not reported. It was unknown if the reporter considered the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at around 5:35 PM. About an hour later, there was a rather violent twitching of the muscle at the injection site but the rest of the muscle was relaxed. The patient thought that was odd. On the next day of vaccination, the patient experienced severe joint pain, raging headache, extreme fatigue (on day two and three). The patient also experienced injection site and area about 3 inches diameter, which was hard, intensely red, and very painful, which went through day four (on the date of reporting). The joint pain continued but at a milder level. The above two experienced from day two through day four. The patient had no idea when this would subside.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Muscle twitching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received SHINGRIX. On 18th February 2019, 1 hr after receiving SHINGRIX, the patient experienced muscle twitching. On 19th February 2019, the patient experienced headache, fatigue, injection site pain, injection site erythema, injection site induration and joint pain. On an unknown date, the outcome of the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching were not reported. It was unknown if the reporter considered the headache, fatigue, injection site pain, injection site erythema, injection site induration, joint pain and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at around 5:35 PM. About an hour later, there was a rather violent twitching of the muscle at the injection site but the rest of the muscle was relaxed. The patient thought that was odd. On the next day of vaccination, the patient experienced severe joint pain, raging headache, extreme fatigue (on day two and three). The patient also experienced injection site and area about 3 inches diameter, which was hard, intensely red, and very painful, which went through day four (on the date of reporting). The joint pain continued but at a milder level. The above two experienced from day two through day four. The patient had no idea when this would subside.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Very tired, muscle achey, shivers. Relatively sudden onset.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Very tired, muscle achey, shivers. Relatively sudden onset.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic encephalopathy, Seizure, Sepsis, Transaminases increased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of seizure in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included methotrexate for drug use for unknown indication. Concomitant products included SHINGRIX. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started methotrexate at an unknown dose and frequency. On 21st January 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 13th February 2019, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), unconscious (serious criteria hospitalization and GSK medically significant), foaming at mouth (serious criteria hospitalization), encephalopathy (serious criteria hospitalization and GSK medically significant) and glioma (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced food poisoning (serious criteria hospitalization). The action taken with methotrexate was unknown. On an unknown date, the outcome of the seizure, unconscious, foaming at mouth, encephalopathy, glioma, food poisoning and drug dose administration interval too short were unknown.  It was unknown if the reporter considered the seizure, unconscious, foaming at mouth, encephalopathy, glioma and food poisoning to be related to SHINGRIX. Additional details were provided as follows: On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX earlier than recommended schedule, which led to shortening of vaccination schedule. The reporter agreed to follow up from GlaxoSmithKline.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Encephalopathy, Foaming at mouth, Food poisoning, Glioma, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of seizure in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included methotrexate for drug use for unknown indication. Concomitant products included SHINGRIX. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started methotrexate at an unknown dose and frequency. On 21st January 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 13th February 2019, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), unconscious (serious criteria hospitalization and GSK medically significant), foaming at mouth (serious criteria hospitalization), encephalopathy (serious criteria hospitalization and GSK medically significant) and glioma (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced food poisoning (serious criteria hospitalization). The action taken with methotrexate was unknown. On an unknown date, the outcome of the seizure, unconscious, foaming at mouth, encephalopathy, glioma, food poisoning and drug dose administration interval too short were unknown.  It was unknown if the reporter considered the seizure, unconscious, foaming at mouth, encephalopathy, glioma and food poisoning to be related to SHINGRIX. Additional details were provided as follows: On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX earlier than recommended schedule, which led to shortening of vaccination schedule. The reporter agreed to follow up from GlaxoSmithKline.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Seizure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of seizure in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included methotrexate for drug use for unknown indication. Concomitant products included SHINGRIX. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started methotrexate at an unknown dose and frequency. On 21st January 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 13th February 2019, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), unconscious (serious criteria hospitalization and GSK medically significant), foaming at mouth (serious criteria hospitalization), encephalopathy (serious criteria hospitalization and GSK medically significant) and glioma (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced food poisoning (serious criteria hospitalization). The action taken with methotrexate was unknown. On an unknown date, the outcome of the seizure, unconscious, foaming at mouth, encephalopathy, glioma, food poisoning and drug dose administration interval too short were unknown.  It was unknown if the reporter considered the seizure, unconscious, foaming at mouth, encephalopathy, glioma and food poisoning to be related to SHINGRIX. Additional details were provided as follows: On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX earlier than recommended schedule, which led to shortening of vaccination schedule. The reporter agreed to follow up from GlaxoSmithKline.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Electroencephalogram, Headache, Loss of personal independence in daily activities, Medical induction of coma
Clinical narrative: Severe headache, could not function, by July 7th developed seizures and put in medically induced coma at medical center developed saddle blood clot. Was hospitalized until August 10, 2018. Still on seizure medication and blood thinners.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Seizure, Thrombosis, Ultrasound Doppler, X-ray
Clinical narrative: Severe headache, could not function, by July 7th developed seizures and put in medically induced coma at medical center developed saddle blood clot. Was hospitalized until August 10, 2018. Still on seizure medication and blood thinners.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4-years-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 22-OCT-2015, the patient, at the age of 12 months, was vaccinated with the first dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, subcutaneously, in left lateral tight, lot number L023111, expiration date 24-DEC-2016, for prophylaxis (exact dose was not reported). On 13-NOV-2018, the patient, at the age of 4-year-old, was vaccinated with the second dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, subcutaneously, in left lateral tight, lot number R022568, expiration date 04-FEB-2020, for prophylaxis (exact dose was not reported). On 08-FEB-2019, the patient, at the age of 4-year-old, the third dose of PROQUAD, albumin status recombinant Human albumin (rHA), injection, was administrated inadvertently (subcutaneous, in left lateral tight, lot number R011803, expiration date 21-OCT-2019). No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 12-month-old patient. Concomitant therapy included PREVNAR 13. Information about medical history and concurrent conditions were not provided. On 19-FEB-2019, the patient was vaccinated with 2 doses of VARIVAX (strength, dose detail, route, lot # and expiration date were not reported) and 2 doses of VAQTA (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis (incorrect dose administered). No adverse symptoms reported.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 10-year-old female patient. The information about the patient's medical history, concomitant medication, concurrent conditions and drug reactions/allergies was unknown by the reporter. On 08-FEB-2019, the patient received a dose of M-M-R II subcutaneously (lot number N032427 and expiration date 16-NOV-2019) for prevention of measles/mumps/rubella (prophylaxis). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date unknown by the reporter). On 19-FEB-2019, following the administration of M-M-R II, the patient developed a fever between 99 Fahrenheit degrees and 101 Fahrenheit degrees and a rash described as "little bumps" on her cheeks and back (pyrexia and rash). It was reported that the patient called the pharmacist due to the events. No treatment was given for the adverse events and it was unknown by the reporter if lab diagnostics/studies were performed. At the time of reporting, the patient had not recovered for the events and there was no causality assessment provided between the events and M-M-R II and sterile diluent (MERCK STERILE DILUENT).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with an expired dose of GARDASIL 9, lot # M030380, expiry date: 01-FEB-2019, for prophylaxis (dose # and route were not reported). No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Injection site oedema
Clinical narrative: Information has been received from an unspecified reporter via a company representative referring to an 11 years old male patient. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient had edema measuring 4cm at the injection site of GARDASIL 9. Outcome of the event was unknown. Causality was not reported.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This spontaneous report was received via Pfizer from a physician which in turn reported to him by a pharmacist, refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 04-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. On 04-OCT-2018, patient was vaccinated with influenza virus vaccine (unspecified) (manufacturer, dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. The patient received both the vaccines in the same arm at different injection sites (product administered at inappropriate site). On an unknown date in October 2018 after the vaccination, the patient experienced redness (erythema), swelling and rash. The patient reported the reactions to the pharmacy on 07-OCT-2018. The outcome of product administered at inappropriate site, erythema, swelling and rash was unknown. Causality assessment of the events erythema, swelling and rash was not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 69 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician's office for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2012, at approximately 74 years of age, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was provided. On 04-MAR-2019, the patient was vaccinated with expired dose of ROTATEQ vial, orally, lot # R000911, expiration date: 28-FEB-2019 (exact dose was not reported) for prophylaxis. The ROTATEQ did not have any temperature excursions prior to administration. No adverse symptoms reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of cellulitis in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis 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 it was captured as adult as per vaccine indication.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Feeling abnormal, Headache, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hiatal hernia and esophageal acid reflux. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (1st dose of SHINGRIX and Flu vaccine, refer case US2019GSK038438). Concurrent medical conditions included rheumatoid factor positive. On 26th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, bone pain, headache, chills, pain of skin and feeling bad. On an unknown date, the outcome of the general body pain, bone pain, headache and chills were not recovered/not resolved and the outcome of the pain of skin and feeling bad were unknown. It was unknown if the reporter considered the general body pain, pain of skin and feeling bad to be related to SHINGRIX. The reporter considered the bone pain, headache and chills to be related to SHINGRIX. Additional details were reported as follows: The reporting dentist was the concerned patient. The day of reporting, the patient was experiencing pain all over her body, headache, and chills. The patient stated that every bone hurts. The patient's skin hurt and she felt like she was on her death bed. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hiatal hernia and esophageal acid reflux. Previously administered products included SHINGRIX with an associated reaction of injection site pain and flu vaccine with an associated reaction of injection site pain (1st dose of SHINGRIX and Flu vaccine, refer case US2019GSK038438). Concurrent medical conditions included rheumatoid factor positive. On 26th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, bone pain, headache, chills, pain of skin and feeling bad. On an unknown date, the outcome of the general body pain, bone pain, headache and chills were not recovered/not resolved and the outcome of the pain of skin and feeling bad were unknown. It was unknown if the reporter considered the general body pain, pain of skin and feeling bad to be related to SHINGRIX. The reporter considered the bone pain, headache and chills to be related to SHINGRIX. Additional details were reported as follows: The reporting dentist was the concerned patient. The day of reporting, the patient was experiencing pain all over her body, headache, and chills. The patient stated that every bone hurts. The patient's skin hurt and she felt like she was on her death bed. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Flushing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of facial flushing in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included osteoarthritis. On 20th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2019, 2 hrs after receiving SHINGRIX, the patient experienced facial flushing. On 21st February 2019, the patient experienced joint pain and fatigue. On an unknown date, the outcome of the facial flushing was recovered/resolved and the outcome of the joint pain and fatigue were not recovered/not resolved. It was unknown if the reporter considered the facial flushing, joint pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. About 2 hours after vaccination, the patient's face felt flushed. The next morning, 1 day after vaccination, the patient reported that when she got out of bed, she was fatigued, her feet hurt at the joints, her hand joints hurt, her knees hurt, and her ankles hurt. The patient reported the pain level as 4 out of 10. At time of report, in February 2019, only the face flushing had resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received SHINGRIX. On 27th February 2019, less than a day after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After vaccination with Shingrix they were diagnosed with the infection. The physician examined the patient same day post vaccination and diagnosed the shingles infection. No additional details provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles 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 reported but the patient could be 82 or 83 years old. The patient was diagnosed with shingles. No batch number or expiry date for SHINGRIX was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles 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 reported but the patient could be 82 or 83 years old. The patient was diagnosed with shingles. No batch number or expiry date for SHINGRIX was provided.
Sex: M
Vaccine: DTAP
Symptoms: Autism spectrum disorder, Developmental regression, Hypersensitivity, Seizure, Sensory disturbance
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case is linked with 2019SA062563 (same reported, patient's brother). This case involves a child male patient (age unknown) who experienced seizures, sensory issues and allergies and autism with developmental regression, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patients past vaccinations, history, concomitant medication were not provided. Family history included patient brother has Autism. Patient's mother reported that her children were normal and then started to regress. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious seizures (seizure) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious autism (Autism spectrum disorder) with started to regress (Developmental regression) unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious sensory issues (sensory disturbance) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious allergies (hypersensitivity) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Final diagnosis was allergies, sensory issues and seizures and Autism. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for seizures, as Unknown for sensory issues and as Unknown for allergies and not recovered for Autism and developmental regression. According to reporter adverse event is related to vaccine. List of documents held by sender- none.; Sender's Comments: This case concerns a child patient with history of autism who developed seizures, sensory issues and allergies following vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pyrexia
Clinical narrative: *Vaccine maladministered subcutaneously instead of approved intramuscular route. Pt reported fever of 101*F on 3/6/19.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling, Peripheral swelling
Clinical narrative: Severe swelling on left arm starting several hours after injection on Monday. Visit to ER on Wednesday 8 AM. Swelling had progressed from injection site to just above wrist. No fever, chills or other symptoms. ER PA diagnosed Cellulitis and prescribed Doxycycline 100 mg for 7 day course. On seventh day, swelling has almost completely gone down. No other adverse effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Hyperaemia, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient developed redness/itchiness on 2/14/19 on left and right upper arms at sites of immunizations. Mom reports he was scratching a lot and his upper two arms became swollen, painful, and warm over the next 2 days. He developed a fever, and given the redness/swelling at the site, Mom brought him to Emergency Department on 2/15/19. He had no cough, difficulty breathing, vomiting, diarrhea, or rash on other parts of his body. In the ER, he had about a 10cm area of warmth, erythema, and swelling extending from shoulder to upper triceps on left upper extremity and a 4-5cm area of erythema and swelling on right upper extremity, consistent with cellulitis. An ultrasound of the area of erythema/induration on his arms showed no fluid collection. Due to the rapid progression of the erythema and fever, he was admitted for IV antibiotic therapy. IV clindamycin was continued throughout his admission and switched to PO once he showed signs of clinical improvement. He was discharged with improved symptoms on 2/17/19 to complete a 7 day course of PO clindamycin. He followed up in clinic on 2/28/19 and swelling/erythema had completely resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Oedema, Pyrexia
Clinical narrative: Patient developed redness/itchiness on 2/14/19 on left and right upper arms at sites of immunizations. Mom reports he was scratching a lot and his upper two arms became swollen, painful, and warm over the next 2 days. He developed a fever, and given the redness/swelling at the site, Mom brought him to Emergency Department on 2/15/19. He had no cough, difficulty breathing, vomiting, diarrhea, or rash on other parts of his body. In the ER, he had about a 10cm area of warmth, erythema, and swelling extending from shoulder to upper triceps on left upper extremity and a 4-5cm area of erythema and swelling on right upper extremity, consistent with cellulitis. An ultrasound of the area of erythema/induration on his arms showed no fluid collection. Due to the rapid progression of the erythema and fever, he was admitted for IV antibiotic therapy. IV clindamycin was continued throughout his admission and switched to PO once he showed signs of clinical improvement. He was discharged with improved symptoms on 2/17/19 to complete a 7 day course of PO clindamycin. He followed up in clinic on 2/28/19 and swelling/erythema had completely resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient developed redness/itchiness on 2/14/19 on left and right upper arms at sites of immunizations. Mom reports he was scratching a lot and his upper two arms became swollen, painful, and warm over the next 2 days. He developed a fever, and given the redness/swelling at the site, Mom brought him to Emergency Department on 2/15/19. He had no cough, difficulty breathing, vomiting, diarrhea, or rash on other parts of his body. In the ER, he had about a 10cm area of warmth, erythema, and swelling extending from shoulder to upper triceps on left upper extremity and a 4-5cm area of erythema and swelling on right upper extremity, consistent with cellulitis. An ultrasound of the area of erythema/induration on his arms showed no fluid collection. Due to the rapid progression of the erythema and fever, he was admitted for IV antibiotic therapy. IV clindamycin was continued throughout his admission and switched to PO once he showed signs of clinical improvement. He was discharged with improved symptoms on 2/17/19 to complete a 7 day course of PO clindamycin. He followed up in clinic on 2/28/19 and swelling/erythema had completely resolved.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Disturbance in attention, Fatigue, Hand-foot-and-mouth disease
Clinical narrative: Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Infection susceptibility increased, Influenza, Menstruation irregular, Nasopharyngitis, Polycystic ovaries
Clinical narrative: Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Weight increased
Clinical narrative: Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Disease susceptibility, Disturbance in attention, Fatigue
Clinical narrative: Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hand-foot-and-mouth disease, Influenza, Menstruation irregular, Nasopharyngitis, Polycystic ovaries
Clinical narrative: Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Dyspnoea, Feeling hot, Headache, Pain
Clinical narrative: Client had Hepatitis A vaccine during an outreach at the Shelter. Client denied any allergies or illness prior to the vaccine. This nurse reviewed the purpose of the vaccine, how the vaccine was delivered and the screened client for any previous reactions to Hepatitis A vaccine. Client allowed to view the Hepatitis A VIS prior to the vaccine. The Hepatitis A vaccine was given in client's left deltoid without a problem. Client reports the next day 3/1/2019 she (client) had " shortness of breath,chills, body aches, and headache". Client reports she felt "warm" but "did not have fever".
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiovascular evaluation, Contusion, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test normal
Clinical narrative: Woke up in middle of night w numbness in right arm. Thought it might be a stroke. Following days and nights with tingling in hands and feet, an extreme and persistent pain bottom of right forearm similar to a bad bruise and continuing intermittent numbness in both arms during night while sleeping. No reaction at injection site. I am healthy and this vaccine was the only change in my health history..  Symptoms continued for weeks so I made an Appt for 2-16-2019 for 5 health screenings--Carotid Artery Disease, Atrial Fib,, Abdominal Aortic Aneurysm, Peripheral Arterial Disease and numerous other tests ruling out heart/stroke risks.