chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Ophthalmic herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: posterior vitreous detachment; herpes keratitis; postherpetic neuralgia; herpes zoster/shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 13-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered severe headaches with a vesicular rash on the left side of the forehead accompanied by blurred vision in the left eye. The patient was diagnosed with herpes zoster/shingles, post herpetic neuralgia, herpes keratitis (herpes ophthalmic) and posterior vitreous detachment. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reported considered all the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered that the herpes zoster, post herpetic neuralgia, herpes ophthalmic and vitreous detachment were disabling events.  Upon internal review, the vitreous detachment and herpes ophthalmic were medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred, Vitreous detachment
Clinical narrative: posterior vitreous detachment; herpes keratitis; postherpetic neuralgia; herpes zoster/shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 13-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered severe headaches with a vesicular rash on the left side of the forehead accompanied by blurred vision in the left eye. The patient was diagnosed with herpes zoster/shingles, post herpetic neuralgia, herpes keratitis (herpes ophthalmic) and posterior vitreous detachment. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reported considered all the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered that the herpes zoster, post herpetic neuralgia, herpes ophthalmic and vitreous detachment were disabling events.  Upon internal review, the vitreous detachment and herpes ophthalmic were medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis viral, Deafness neurosensory, Sudden hearing loss, Vision blurred, Visual impairment
Clinical narrative: severe sensorineural hearing loss; viral conjunctivitis; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 14-APR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered sudden hearing loss in his left ear and was diagnosed with severe sensorineural hearing loss (deafness neurosensory). The patient also suffered sudden bilateral blurry vision and decreased vision and was diagnosed with viral conjunctivitis. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reported considered all the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered that the deafness neurosensory and viral conjunctivitis were disabling events.  Upon internal review, the deafness neurosensory was a medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Pneumonia, Respiratory tract congestion
Clinical narrative: pneumonia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 27-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered chronic cough and congestion and was diagnosed with pneumonia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  It was considered by the reporter that the pneumonia was a disabling event.  Upon internal review, the pneumonia was a medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Demyelinating polyneuropathy, Dyspnoea, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain-Barre Syndrome/acute infective polyneuritis; acute inflammatory demyelinating polyneuropathy; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 04-MAR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered progressive weakness in his lower extremities and shortness of breath as well as upper extremity symptoms. The patient was hospitalized and diagnosed with Guillain-Barre Syndrome/acute infective polyneuritis and acute inflammatory demyelinating polyneuropathy (demyelinating polyneuropathy). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered by the reporter that demyelinating polyneuropathy and Guillain-Barre Syndrome were disabling events.  Upon internal review, the demyelinating polyneuropathy and Guillain-Barre Syndrome were medically significant events.
Sex: U
Vaccine: PPV, PPV, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were administered a dose of improperly stored PNEUMOVAX 23; No adverse symptoms were reported; This initial spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On unknown dates, the patients were vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S013489, expiration date 06-MAR-2021; lot# S029916, expiration date 12-JUN-2021; dose, strength and route were not provided) for prophylaxis. The temperature excursions included below 2 degree Celsius (0 degree Celsius) for 80 hours and 49 minutes, below 0 degree Celsius (-0.6 degree Celsius) for 37 hours and 20 minutes (29 cycles). There was no previous temperature excursion. There was a data logger involved. No adverse symptoms were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:  manufacturercity: manufacturerstate: ; manufacturercountry:; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood test, Dizziness, Heart rate increased, Nausea
Clinical narrative: heart rate today is 130 which is increased from heart rate yesterday of 100; light-headedness; nausea; The primary reporter is the patient who stated he received the second dose of the GARDASIL 9 vaccination on 02/29/2020/; This spontaneous report was received from a 40 years old male patient referring to himself. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.  On 29-FEB-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (one injection, lot # R036912, expiration date 23-SEP-2021; dose was not reported) via intramuscular for better protect himself from cancer ((prophylaxis)(PT: product use issue)).  On the same date, one hour after receiving his second dose, the patient began experiencing light-headedness and nausea. No treatment was given for adverse events. Blood work was performed (no result was provided). The patient had sought medical attention, he went to primary care. On 03-MAR-2020 (reported as today) the patient's heart rate was 130 (unit not provided) which was increased from heart rate on 02-MAR-2020 (reported as yesterday) of 100 (unit not provided).  Outcome of light-headedness and nausea was not recovered. Outcome of heart rate increased was unknown. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R036912; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; on 3/3/2020, one dose of VARIV AX which expired on 2/29/2020, was administered to the patient; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 03-MAR-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency, and route of administration were not reported) (lot # R006221, expiration date 29-FEB-2020) as prophylaxis, no adverse effects were reported.
Sex: U
Vaccine: ANTH
Symptoms: Cardiomegaly, Injection site reaction, Pulmonary oedema
Clinical narrative: Swelling on heart and lungs; Swelling on heart and lungs; Other symptoms and medical issues in left arm and shoulder where vaccine was administered; Spontaneous report received on 22FEB2020.  A consumer reported swelling on heart (PT: Cardiomegaly) and swelling on lungs (PT: Pulmonary oedema) and had other symptoms and medical issues in left arm and shoulder where the vaccine was administered (PT: Injection site reaction) following immunisation with Anthrax vaccine (anthrax vaccine adsorbed). On 20JUL2011, the consumer received anthrax vaccine (lot number: FAV248) and one other vaccine (unspecified). The consumer had swelling on heart and lungs and had other symptoms and lot of medical issues, particularly in the left arm and shoulder where the consumer received the vaccine. The outcome of the reported events was unknown at the time of report.  Company Comment: A consumer received BioThrax vaccination along with other unknown vaccine and developed injection site reaction along with swelling on heart and lungs (Cardiomegaly and Pulmonary oedema). Information on medical history, concomitant medications, and further details of the events is limited. Considering the limited information regarding onset of events - as the patient received vaccine 9 years ago, diagnoses, or patient medical history where patient developed cardiomegaly and pulmonary oedema after receiving BioThrax, causality of both the events is considered not assessable. The case is also confounded by unknown concomitant vaccine administration. BioThrax can cause local injection site reaction and the causality of the event is assessed as possible. The case is considered serious due to medical significance of the events cardiomegaly and pulmonary oedema which are unlisted as per.; Sender's Comments: Company Comment: A consumer received BioThrax vaccination along with other unknown vaccine and developed injection site reaction along with swelling on heart and lungs (Cardiomegaly and Pulmonary oedema). Information on medical history, concomitant medications, and further details of the events is limited. Considering the limited information regarding onset of events - as the patient received vaccine 9 years ago, diagnoses, or patient medical history where patient developed cardiomegaly and pulmonary oedema after receiving BioThrax, causality of both the events is considered not assessable. The case is also confounded by unknown concomitant vaccine administration. BioThrax can cause local injection site reaction and the causality of the event is assessed as possible. The case is considered serious due to medical significance of the events cardiomegaly and pulmonary oedema which are unlisted as per.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: On February 20th after my second vaccine, I broke out with shingles / Suspected vaccination failure; shingles on my palate; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 20th February 2020, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. On 20th February 2020 after second vaccine, patient broke out with shingles on his or her palate. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter requesting consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Lip dry, Oral herpes, Rash, Rash erythematous
Clinical narrative: dry skin on his legs /dryness on the legs; cold sore; dry lip; red rash around the hose; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 31st March 2022) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 2 weeks after receiving Shingrix and not applicable after starting acyclovir, the patient experienced cold sores, lip dry and red rash. On 15th February 2020, the patient experienced dry skin. The patient was treated with acyclovir. On an unknown date, the outcome of the cold sores, lip dry, red rash and dry skin were unknown.   It was unknown if the reporter considered the cold sores, lip dry, red rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient stated experienced a cold sore.  The patient took acyclovir for 3 days.  The patient experienced dryness on the legs on 15th February 2020 or 16th February 2020. On 17th February patient went to the pharmacy complaining of extreme dry lip, red rash around the nose.  The health care professional (HCP) states that the patient's symptoms were the worst on the 19th and 20th day following administration. The patient was better on 17th February 2020 but was still complaining of symptoms.  The HCP spoke to the patient on Monday night and they were feeling better than they were on Monday morning.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia
Clinical narrative: splitting headache; inability to sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 18th February 2020, the patient experienced headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the headache and insomnia to be related to Shingrix.  Additional details were received as follows: The patient received 2nd dose of Shingrix in left arm at her doctor's office. The patient experienced   splitting headache that evening causing an inability to sleep. The patient had taken 2 Advil approximately 30 minutes and it has not helped. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: fever / feeling fever symptoms; chills; swelling near the armpit / swelling under her armpits; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced fever, chills and local swelling. On an unknown date, the outcome of the fever, chills and local swelling were unknown.   It was unknown if the reporter considered the fever, chills and local swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received 2nd dose of Shingrix 2 to 3 days before the reporting date and experienced fever, chills and a swelling near the armpit on the left side where the vaccine was injected. The reporter consented to follow up. This case was received from healthcase provider via the assistance program.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: unspecified severe reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. Approximately 18th september 2019, the patient received 1st dose of Shingrix on the left arm and had an unspecified severe reaction. The reporter did not describe the severe reaction. The reporter declined to provide further information for safety report.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction
Clinical narrative: redness that increased 3 times in size by now; This case was reported by a physician via call center representative and described the occurrence of erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4EB9Y, expiry date 21st February 2022) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The patient had local adverse reactions follwing the vaccination. At the time of reporting, the redness was increased 3 times in size. The reporter asked how long these adverse reactions going to last. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th September 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix on an unknwon arm. The patient had arm pain at injection site. This case has been linked with case US2020033088, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: unable to lift arm; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 26th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 2nd January 2020, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's husband. The patient received 2nd dose of Shingrix on the right deltoid. The patient experienced pain at injection site and was unable to lift her arm. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with case US2020033080 (husband's case), reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Rash papular
Clinical narrative: raised, round, red patches on her hands and feet; raised, round, red patches on her hands and feet; This case was reported by a consumer via call center representative and described the occurrence of redness of legs in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced redness of legs. On an unknown date, the outcome of the redness of legs was unknown.   It was unknown if the reporter considered the redness of legs to be related to Shingrix.  Additional details were provided as follows: The patient experienced raised, round, red patches on her hands and feet and that they would come and go and then reappear in other locations, mostly on hands and feet and occasionally on neck.   She informed that more recently they were flat and not itchy. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Asthenia, Decreased appetite, Feeling abnormal, Thirst
Clinical narrative: almost felt like she was hallucinating; felt very weak; had bizarre  dreams; was very thirsty; had no appetite; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 10 hrs after receiving Shingrix, the patient experienced feeling abnormal, weakness, bizarre dreams, thirst and appetite absent. On an unknown date, the outcome of the feeling abnormal, weakness, bizarre dreams, thirst and appetite absent were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, weakness, bizarre dreams, thirst and appetite absent to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of Shingrix on 28th September 2019 or 28th September 2019, around 2 PM. Around midnight or 1 AM she started experiencing side effects.  The patient felt very weak and had bizarre  dreams. She said it almost felt like she was hallucinating. The patient was very thirsty and had no appetite. She was in bed for 2 days because of the symptoms.  The symptoms were resolved after about 2 days. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test, Chest X-ray normal, Chills, Cough
Clinical narrative: Arm hurt and was painful to touch.  After 7 hours I started with a headache followed by stomach ache.  Then diarrhea and severe chills that would not stop until I got into a hot shower and then used heating pad and got under blankets.  Then the body aches all night long.  The next day I could not go to work.  Then 3 days later I came down with fever, aches, and coughing and have been sick on a off since, which has been 3 weeks. I fell the reaction to this vaccine wiped out my immune system.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Impaired work ability, Malaise, Pain
Clinical narrative: Arm hurt and was painful to touch.  After 7 hours I started with a headache followed by stomach ache.  Then diarrhea and severe chills that would not stop until I got into a hot shower and then used heating pad and got under blankets.  Then the body aches all night long.  The next day I could not go to work.  Then 3 days later I came down with fever, aches, and coughing and have been sick on a off since, which has been 3 weeks. I fell the reaction to this vaccine wiped out my immune system.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Arm hurt and was painful to touch.  After 7 hours I started with a headache followed by stomach ache.  Then diarrhea and severe chills that would not stop until I got into a hot shower and then used heating pad and got under blankets.  Then the body aches all night long.  The next day I could not go to work.  Then 3 days later I came down with fever, aches, and coughing and have been sick on a off since, which has been 3 weeks. I fell the reaction to this vaccine wiped out my immune system.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling and pain in left arm.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Longer than recommended interval between first and second dose; No adverse effects reported.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender. No information regarding, the patient's medical history, concurrent conditions and concomitant medications was provided. On an unspecified date in December 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (strength, route of administration, lot # and expiration date were not reported) for prophylaxis. On 22-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route of administration, lot # and expiration date were not reported), that was considered as an inappropriate schedule of product administration. There was no adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: rash; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was allergic to latex. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, after receiving a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient developed rash for an unknown period of time. The patient sought medical attention by seeing an unspecified provider. The patient received prednisone as a treatment for the event. The outcome of rash and the relatedness between the rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: muscle pain/ muscle ache in the area of the shot; soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and pain. On an unknown date, the outcome of the injection site pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain 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 was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced muscle pain, soreness and injection site pain. The reporter wanted to know how long does it lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2020, between 1 and 3 months 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. The patient received Shngrix a little over 2 months before the date of reporting. In the last week from the date of reporting, patient had shingles before getting 2nd dose. The patient was asking whether he/she need to wait a year and get both shots again and if he/she need to get 2nd dose after shingles clear up within 6 months of 1st dose.
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Vaccination failure
Clinical narrative: supress my immune system; I was given 2 shots of sangria in 2018 6 months apart / came down with shingles (diagnosed by a doctor); Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and omalizumab (Xolair) for anaphylaxis.   Concurrent medical conditions included anaphylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Xolair at an unknown dose and frequency. In February 2020, less than 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported, however it was captured as adult as per vaccine indication. In 2018, the patient received the 1st and 2nd dose of Shingrix with an interval of 6 months. The patient was not experimenting. The patient was diagnosed with Shingles. The patient asked if this side effect could occur 2 years later. It was reported that as compared with placebo, Shingrix significantly reduced the risk of herpes zoster by 97.2 percent in patients 50 years and older. Compared with placebo, Shingrix significantly reduced the risk of developing herpes zoster by 91.3 percent in patients 70 years and older. The patient tried to figure out why he or she had developed shingles despite being vaccinated.  The patient had recently started Xolair injections for anaphylaxis and wondered if the drug could suppress immune system enough to cause an outbreak of herpes zoster. In the package insert under drug interactions it was stated that immunosuppressive therapies might reduce the effectiveness of Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Xolair. This case was considered as suspected vaccination failure as lab tests confirming varicella zoster virus infection was unknown at the time of reporting.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: shivers; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received Shingrix (intramuscular) .5 ml. On 18th November 2019, 1 days after receiving Shingrix, the patient experienced shivers and tiredness. On 19th November 2019, the outcome of the shivers and tiredness were recovered/resolved.   It was unknown if the reporter considered the shivers and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received Shingrix and experienced tiredness and shivers for 1 day. This case linked with US2020031411, reported for patient's husband.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Fatigue, Injection site pain, Magnetic resonance imaging
Clinical narrative: pain during injection; feeling weak; shoulder pain and weakness; felt like a nerve was being hit; Fatigue; Bedridden; felt like a nerve was being hit; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue and bedridden to be related to Shingrix.  Additional details were provided as follows: After receiving the 1st dose of Shingrix the patient experienced pain at time of injection, described it as if it felt like a nerve was being hit also experienced feeling weak and was on the couch for three days, and since the first dose she has had persistent shoulder pain and weakness. The patient been seen by an orthopedist and had an Magnetic resonance imaging done to evaluate this issue. The reported suspected the 1st dose was administered too high on her arm and might had hit a nerve or the joint sack, which led to vaccine administered at inappropriate site. The patient emergency room visit required. On 15th November 2019, the patient received 2nd dose and she had no issues. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nerve injury, Product administered at inappropriate site
Clinical narrative: pain during injection; feeling weak; shoulder pain and weakness; felt like a nerve was being hit; Fatigue; Bedridden; felt like a nerve was being hit; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue and bedridden to be related to Shingrix.  Additional details were provided as follows: After receiving the 1st dose of Shingrix the patient experienced pain at time of injection, described it as if it felt like a nerve was being hit also experienced feeling weak and was on the couch for three days, and since the first dose she has had persistent shoulder pain and weakness. The patient been seen by an orthopedist and had an Magnetic resonance imaging done to evaluate this issue. The reported suspected the 1st dose was administered too high on her arm and might had hit a nerve or the joint sack, which led to vaccine administered at inappropriate site. The patient emergency room visit required. On 15th November 2019, the patient received 2nd dose and she had no issues. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hangover, Injection site pain
Clinical narrative: Chills; feeling tired; feeling weak; it feels like he has a hangover; pain is mostly in his left shoulder; Pain upon movement; painful when he lifts his arm; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, shoulder pain and pain upon movement. On 21st February 2020, the patient experienced chills, tiredness, feelings of weakness and hangover. On an unknown date, the outcome of the chills, injection site pain, tiredness, feelings of weakness and pain in arm were not recovered/not resolved and the outcome of the hangover, shoulder pain and pain upon movement were unknown.   It was unknown if the reporter considered the chills, injection site pain, tiredness, feelings of weakness, pain in arm, hangover, shoulder pain and pain upon movement to be related to Shingrix.  Additional details were provided as follows: On 20th February 2020, at 7:00 PM the patient received 2nd dose of Shingrix. On 21st February 2020, at morning, the patient began to experience soreness at the injection site and it was painful when he lifts his arm.  The pain was mostly in his left shoulder. The patient reported feeling tired, weak, and having chills and felt like hangover.  The patient given permission for his physician to be contacted. Unable to obtain additional details.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Chills; feeling tired; feeling weak; it feels like he has a hangover; pain is mostly in his left shoulder; Pain upon movement; painful when he lifts his arm; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, shoulder pain and pain upon movement. On 21st February 2020, the patient experienced chills, tiredness, feelings of weakness and hangover. On an unknown date, the outcome of the chills, injection site pain, tiredness, feelings of weakness and pain in arm were not recovered/not resolved and the outcome of the hangover, shoulder pain and pain upon movement were unknown.   It was unknown if the reporter considered the chills, injection site pain, tiredness, feelings of weakness, pain in arm, hangover, shoulder pain and pain upon movement to be related to Shingrix.  Additional details were provided as follows: On 20th February 2020, at 7:00 PM the patient received 2nd dose of Shingrix. On 21st February 2020, at morning, the patient began to experience soreness at the injection site and it was painful when he lifts his arm.  The pain was mostly in his left shoulder. The patient reported feeling tired, weak, and having chills and felt like hangover.  The patient given permission for his physician to be contacted. Unable to obtain additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: erythema; pain; redness; heat; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On 21st February 2020, the patient experienced erythema. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the erythema was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient experienced pain, redness and heat at the injection site since receiving the vaccine.  On the day of reporting, the reporter noticed a line running down his arm from the injection site, extending a ways past the circle of redness.