chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: Patient received single dose vial of PREVNAR 13 in left upper arm late morning on Dec 6th 2018. Patient reported to me, her daughter, that next morning, Dec 7th 2018, she was violently vomiting, was dizzy, and felt very weak. Patient also developed fever that day. Patient then stated that during night time hours into the following morning of Saturday Dec 8 2018, she was still feverish and had profuse sweating. Fever then dissipated on Saturday Dec 8 2018. Following day Sunday Dec 9th patient was homebound and felt very dizzy and weak. She did not want to go to the urgent care clinic as she thought this was a reaction to the injection and was told by the RN that she was sensitive to it and the reaction was normal. On Tuesday Dec 10th around 5 PM in the afternoon, the patient showed me her left upper arm where the injection took place as she said it was very sore. The arm was bright red from the shoulder down to the elbow, swollen and very hot to the touch. I immediately called Dr.'s office, but it was closed. The On Call triage nurse advised that she should be seen by Dr. the next day and to use warm moist compresses on the site to alleviate pain. Patient was then seen by Dr. on Wednesday Dec 11th and was given a 7 day dose of antibiotics for cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Injection site warmth
Clinical narrative: Rash and heat around injection site about four inches, joint pain.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt was due for MMR and Varicella separately but a PROQUAD and Varicella was given.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was administered with improperly stored VAQTA (lot # R018935, expiry date: 05-SEP-2019) for prophylaxis. Dosing details were unknown for the vaccine. No adverse effect reported. The temperature excursion occurred between 0 degree Celsius to 1 degree Celsius (0.5 degree Celsius multiple) for a time frame of 13 hours and 18 minutes. There were no previous temperature excursions occurred. Data logger was involved. No product quality complaint was involved. This is one of the two reports received from the same reporter (cross linked case reference: 812USA006429).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine, Blood urea, Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: This spontaneous report was received from a nurse licensed practical refers to a 69 years old female patient. The patient's concurrent conditions included hyperlipidaemia, irritable bowel syndrome (IBS), cystitis interstitial, osteopenia of lower leg, chronic sinusitis and oestrogen deficiency, the drug reactions (allergy) included: SEPTRA, MACRODANTIN, azithromycin, CRESTOR, BUSPAR, FLAGYL, cefrozil and levofloxacin. The patient's historical conditions and concomitant medications were not reported. On 06-DEC-2018 the patient was administered with PNEUMOVAX 23 lot # R007722, intramuscular for as routine vaccination (dose was not reported). On 07-DEC-2018, experienced redness and edema at the injection site down to the elbow, the patient visited an unspecified emergency room in which she was diagnosed with cellulitis and treated with intravenous antibiotic and was discharged from the emergency room at the same day with a prescription for an antibiotic. Blood Urea Nitrogen and Creatinine tests were conducted, however, the results were not provided. At the time of reporting, the patient was recovering from the event. The causality relationship between the event and PNEUMOVAX 23 therapy was not reported. Upon internal review, cellulitis was determined to be medically significant. The reporter also considered the event as life threatening.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 13-FEB-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-APR-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2008, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a male patient of unknown age. Patient's concurrent conditions included diabetes. Information on patient's medical history, concomitant medications and dug allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, units, anatomical location,route, lot# and expiry were not reported) for prophylaxis. On an unknown date, the patient developed redness (injection site erythema) and itching at the injection site (injection site pruritus) after receiving PNEUMOVAX 23.The patient had received treatment.The patient did not sought medical attention.The outcome of the events was recovered. Causality assessment was not provided. No Product Quality Complaint (PQC) was involved.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Myalgia
Clinical narrative: Muscle soreness that lasted 2 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to be given second dose of SHINGRIX and was give Zoster by mistake. Also Zoster Vaccine had expired 4 months prior to administration. Patient did not report any adverse effects.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV
Symptoms: Discomfort, Ear infection, Extra dose administered, Injection site erythema, Injection site swelling
Clinical narrative: RN inadvertently administered the incorrect DTaP injection to the child. The child received an extra dose of polio. RN called the child's mother. Mom stated the child had redness and swelling at the injection site. Mom stated child was "fussier" than he has normally been when he has gotten his shots before. Mom gave the child TYLENOL and it seemed to help. Mom stated the child also has an ear infection, however she is aware that is not related to his shots. RN apologized to mom for the error and child's discomfort. Mom stated that it is not a problem and she understands and will return for next scheduled appointment.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV
Symptoms: Irritability, Wrong product administered
Clinical narrative: RN inadvertently administered the incorrect DTaP injection to the child. The child received an extra dose of polio. RN called the child's mother. Mom stated the child had redness and swelling at the injection site. Mom stated child was "fussier" than he has normally been when he has gotten his shots before. Mom gave the child TYLENOL and it seemed to help. Mom stated the child also has an ear infection, however she is aware that is not related to his shots. RN apologized to mom for the error and child's discomfort. Mom stated that it is not a problem and she understands and will return for next scheduled appointment.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient reported no adverse reaction until this Monday 12/17 when her arm started getting sore like muscle pain, and traveling to her upper back on the side of the vaccination, it has continued since Monday through today.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain lower, Arthralgia, Back pain, Constipation
Clinical narrative: Diarrhea - day of vaccination and for two days following, lower abdominal cramping now in my 8th day, profuse intestinal gas/bloating for 7 days, lower back/hip/leg pain for 7 days, somewhat constipated that has included very minimal diarrheal-appearing bowel movements (still ongoing on 8th day). Symptoms seem to be subsiding now 8 days post-vaccination, so referral to medical practitioner has not been sought.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Flatulence, Pain in extremity
Clinical narrative: Diarrhea - day of vaccination and for two days following, lower abdominal cramping now in my 8th day, profuse intestinal gas/bloating for 7 days, lower back/hip/leg pain for 7 days, somewhat constipated that has included very minimal diarrheal-appearing bowel movements (still ongoing on 8th day). Symptoms seem to be subsiding now 8 days post-vaccination, so referral to medical practitioner has not been sought.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-DEC-2015, a healthcare provider at the office of a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-JAN-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection site, injection site hot to the touch, painful for 6 days afterwards (and still hurts to touch it), serious fatigue for days after. Due date 2/16/19. Healthy pregnancy so far.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt states soreness on date of vaccination on 12/17/2018. Pt had a physical fitness test on 12/17/2018 in the afternoon time. Pt went to Urgent Care for body pain. Pt prescribed Meloxicam as well muscle relaxer which pt took later that evening. 12/18/2018 pt noticed when she came home from work the right arm was still sore and had developed redness at injection site. Pt also noticed fever of 101.8 and called the nurse advice line for guidance. Nurse advice line said that the symptoms were normal after a vaccine and advised to take TYLENOL for fever. Pt states symptoms stayed the same throughout 12/19-12/20/2018, pt walked into be seen by PCM. PCM stated cellulitis and pt placed on antibiotics.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and mild swelling at injection site, extremely achy, fatigue, headache, gastric upset.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain and mild swelling at injection site, extremely achy, fatigue, headache, gastric upset.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Painful injection site. Muscle aches, Headache. Feels like one feels when they have the flu.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, loss of mobility.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Asthenia, Blood glucose increased, Chest X-ray, Computerised tomogram head
Clinical narrative: Severe headache within 1 hour. Awoke next day with migraine, fever (101), all-over body aches, especially both shoulders, weakness. Slept on and off all day, tried to drink liquids but by 3pm started vomiting every time I sipped anything. Went to ER at 8PM on the advice of my doctor. After a CT scan of my head, xrays, Urine analysis, labs, and pain and nausea meds, I was discharged home. Currently on headache prescription that seems to help. I used to get migraines regularly, but not since menopause 10 years ago.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hepatic enzyme increased, Injection site pain, Laboratory test, Migraine
Clinical narrative: Severe headache within 1 hour. Awoke next day with migraine, fever (101), all-over body aches, especially both shoulders, weakness. Slept on and off all day, tried to drink liquids but by 3pm started vomiting every time I sipped anything. Went to ER at 8PM on the advice of my doctor. After a CT scan of my head, xrays, Urine analysis, labs, and pain and nausea meds, I was discharged home. Currently on headache prescription that seems to help. I used to get migraines regularly, but not since menopause 10 years ago.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Severe headache within 1 hour. Awoke next day with migraine, fever (101), all-over body aches, especially both shoulders, weakness. Slept on and off all day, tried to drink liquids but by 3pm started vomiting every time I sipped anything. Went to ER at 8PM on the advice of my doctor. After a CT scan of my head, xrays, Urine analysis, labs, and pain and nausea meds, I was discharged home. Currently on headache prescription that seems to help. I used to get migraines regularly, but not since menopause 10 years ago.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe headache within 1 hour. Awoke next day with migraine, fever (101), all-over body aches, especially both shoulders, weakness. Slept on and off all day, tried to drink liquids but by 3pm started vomiting every time I sipped anything. Went to ER at 8PM on the advice of my doctor. After a CT scan of my head, xrays, Urine analysis, labs, and pain and nausea meds, I was discharged home. Currently on headache prescription that seems to help. I used to get migraines regularly, but not since menopause 10 years ago.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after IM Injection in Left Deltoid. Patient experienced pain, swelling and heat in area.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Hypersensitivity, Rash generalised, Rash pruritic
Clinical narrative: Injection 12/17 (her 3rd in the series). Within 24 hours, she had a diffuse itchy whole body rash and erythema c/w allergic reaction.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Dizziness, Syncope, Tremor
Clinical narrative: Blood pressure shot up within 5 minutes of injection. Fought multiple episodes of fainting. Shaking and dizziness for about 2 hours.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site pain never went away on 12/18/18 tingling started left hand fingers.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red arm, painful, and swollen at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-JUN-2012, a healthcare provider at a department of health administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-MAR-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a nurse via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, several hours after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The nurse reported that Flu shots getting people sick within hours (it happened to her). The reporter also reported increased autism rate. The reporter had been nurse for over 40 years and believed the correlation needs to be investigated.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hives in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received SHINGRIX .5 ml. On 18th August 2018, 1 days after receiving SHINGRIX, the patient experienced hives and swelling. The patient was treated with ambiguous CLARITIN (Nos). On an unknown date, the outcome of the hives and swelling were recovered/resolved. It was unknown if the reporter considered the hives and swelling to be related to SHINGRIX. Additional details were reported as follows: The symptoms began the morning after the shot. There were no pulmonary symptoms. The physician gave him CLARITIN and the symptoms resolved in 24 hours. The reporter agreed to be followed up and would like to receive a call from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 10th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown. It was unknown if the reporter considered the fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, the patient received 1st dose of SHINGRIX. A day before reporting, the patient received 2nd dose of SHINGRIX. The patient asked how long does the fever and headache usually last and could she take something for it or just wait. The patient reported that she did not felt like this after receiving 1st dose.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, joint pain and general body pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, fever, chills, joint pain and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills, joint pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was the caller and the reported for herself. With 1st dose of SHINGRIX vaccine she experienced soreness and pain at the injection site. Along with fever, chills, joint pain and body ache. The pain at injection site started next day while the other symptoms started within 4 to 6 hours. She took ibuprofen the next day which took care of the fever, chills, joint pain and body ache. The soreness and pain at injection site lasted for about 4 to 5 days. The reporter gave consent to follow up. No further details were provided. Transferred call to medical information vaccines for further information. For tolerance after 2nd dose of SHINGRIX, refer case US2018223314.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Product administration error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 4th September 2018, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced product administration error. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and product administration error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient reported that that she had her dose of SHINGRIX vaccine in her left shoulder area with the flu vaccine, which led to product administration error. It was sore as she expected but it was okay. For tolerance of 2nd dose refer case US2018223354.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (refer case US2018224296). On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema of extremities and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were received as follows: At the noon, the patient received SHINGRIX in the left arm and has redness and soreness again. The redness was above the actual injection site. The reporter said it was more red at the time of reporting than it was an hour before the time of reporting. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 14th May 2018, refer case US2018190915). On 24th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms (serious criteria other: serious as per reporter). On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported but it could be 76 years or 77 years. The patient experienced flu like symptoms. The first two days the patient stayed in the house resting. Less than a month after receiving vaccination, the patient's arm was sore at the injection point. The patient was back to normal after two weeks. The patient was otherwise in good health. The side effects were much more serious with the 2nd vaccine. The reporter reported that initial reason he called GlaxoSmithKline was the lack of availability for the vaccine. The case has been linked to the cases US2018GSK229696 and US2018GSK229702, reporter by the same reporter for patient's wife.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Tremor, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 79-year-old male patient who received SHINGRIX (batch number D9P5X, expiry date 18th April 2021) for prophylaxis. On 22nd November 2018, the patient received the 1st dose of SHINGRIX. On 27th November 2018, 5 days after receiving SHINGRIX, the patient experienced tremor, shivering, nausea and vomiting. On an unknown date, the outcome of the tremor, shivering, nausea and vomiting were unknown. It was unknown if the reporter considered the tremor, shivering, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: In the evening (exact time was not specified), the patient developed shivering, shaking, nausea and vomiting. The patient was taken to the emergency room, treated for these symptoms and released after approximately 7 hours. The patient experienced no further episodes. The emergency room diagnosed the events as, either a reaction to the SHINGRIX or a virus. The pharmacist consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu Seasonal QIV Dresden 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 Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that a relative of her patient might have developed Guillain Barre after a flu vaccine. The Pharmacist did not mention which flu product was given.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cold sores (cold sores in eyes and in nasal passages, about 30 years). In July 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional information received as follows: The patient was never treated for cold sores. The patient noticed a great reduction in episodes with the last being about 3 weeks prior to his 2nd dose of SHINGRIX which was received in mid of November 2018. He did not have anymore cold sores in his eyes or nasal passages. The patient felt GlaxoSmithKline ought to know about this.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cold sores (suffered from severe cold sores all over his body as a symptom from Herpes). In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were reported as follows: After receiving 1st dose of SHINGRIX the patient had not experienced any cold sores. A few weeks before the time of reporting, the patient received 2nd dose of SHINGRIX and believed that the Herpes may be gone for good. The contact details of the physician was provided. The reporter had granted permission to contact his a physician.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without adverse event). 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated that she had fever and chills from the recent SHINGRIX shot. She stated she did not experience these side effects from the first shot of SHINGRIX and she wanted to know how long they would last. The patient declined to provide phone number, her date of birth (DOB) and healthcare provider information. The reporter did not give consent to follow-up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Decreased appetite, Dizziness, Epistaxis, Mood altered
Clinical narrative: Pt experienced arthralgias, fever, anorexia, dizziness, muscle aches, increased episodes of pseudo seizures, nose bleeds, moodiness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Psychogenic seizure, Pyrexia
Clinical narrative: Pt experienced arthralgias, fever, anorexia, dizziness, muscle aches, increased episodes of pseudo seizures, nose bleeds, moodiness.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Initially developed pain and itching at the injection site. Over the next several days, developed a circular rash at injection site and scattered rash to upper arm and other body sites. Injection site has been tender to touch since.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Shaking chills, fever to 101, muscle aches, joint pain, headache. Symptoms started 12:30 AM and lasted till 11:00 PM. Fever responded to Acetaminophen 1000 mg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Shaking chills, fever to 101, muscle aches, joint pain, headache. Symptoms started 12:30 AM and lasted till 11:00 PM. Fever responded to Acetaminophen 1000 mg.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Fatigue, headache, shivering, dizziness, lethargy.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left arm pain. In upper arm and occasionally into shoulder. Pain is where the flu shot was given. Worse with movement but is constant. Hard to turn steering wheel without sharp pain. Flu shot was in November and has had pain since then. Pain got worse last week. Tried ICYHOT without relief.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Rash vesicular, Skin lesion
Clinical narrative: Developed classic presentation of shingles at a young age not having had natural chicken pox or exposure to chicken pox. Only having had the varicella vaccine. Pain improved with Valacyclovir. Rash resolved spontaneously following the natural course of shingles. Symptoms started 11/28/18 with sharp dermatomal pain, but no rash. She was then seen in the office 11/30 with classic vesicular dermatomal rash of shingles. Follow up 12/10/18 showed lesions almost fully resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In January 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.