chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex encephalitis, Mental status changes, Pyrexia, Vomiting
Clinical narrative: vomiting, fever, and mental status changes and was diagnosed with Herpes Simplex encephalitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 02-NOV-2013 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the pt. experienced vomiting, fever, and mental status changes and was diagnosed with herpes simplex encephalitis.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations do not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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 of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review herpes simplex encephalitis was considered to be medically significant event.  Upon internal review the herpes simplex encephalitis was considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Chronic inflammatory demyelinating polyradiculoneuropathy, Disturbance in attention, Dyspnoea, Fatigue
Clinical narrative: lower extremity cellulitis; swelling of extremity; shortness of breath; generalized fatigue/fogginess; difficulty concentrating; Chronic Inflammatory Demyelinating Polyneuritis/ ascending numbness into his extremities which eventually moved into his shoulders and hips; generalized fatigue/fogginess; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 10-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient initially suffered and developed lower extremity cellulitis, swelling of extremity, shortness of breath and generalized fatigue/fogginess and difficulty concentrating. Immediately following these injuries and in relation to the above, he experienced ascending numbness into his extremities which eventually moved into his shoulders and hips. The patient was further diagnosed with chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient 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 of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability.   Upon internal review, the events of cellulitis and chronic inflammatory demyelinating polyradiculoneuropathy were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Peripheral swelling
Clinical narrative: lower extremity cellulitis; swelling of extremity; shortness of breath; generalized fatigue/fogginess; difficulty concentrating; Chronic Inflammatory Demyelinating Polyneuritis/ ascending numbness into his extremities which eventually moved into his shoulders and hips; generalized fatigue/fogginess; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 10-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient initially suffered and developed lower extremity cellulitis, swelling of extremity, shortness of breath and generalized fatigue/fogginess and difficulty concentrating. Immediately following these injuries and in relation to the above, he experienced ascending numbness into his extremities which eventually moved into his shoulders and hips. The patient was further diagnosed with chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient 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 of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability.   Upon internal review, the events of cellulitis and chronic inflammatory demyelinating polyradiculoneuropathy were determined to be medically significant.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired self-care, Loss of consciousness, Malaise, Neurological symptom, Vaccination complication
Clinical narrative: passed out; the patient was told that she had a neural disease. She thinks it was multiple sclerosis; very sick; not good at taking care of herself; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, also reported as "sometime after receiving the vaccine", the patient became very sick (illness) and passed out (loss of consciousness). The patient went to the emergency room (ER) and she was told that it was due to a reaction of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) shot. On an unknown date, noted as "later", the patient was told that she had a neural disease and the reporter thought it was multiple sclerosis. The reporter stated that there was a lot of information that she did not know because her sister was not good at taking care of herself (Impaired self-care) and following up with her physicians about her health. The patient sough medical attention. It was unknown by the reporter if any treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the events was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events was not reported.  Upon internal review, the events passed out and multiple sclerosis were determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA006556: US-009507513-2107USA006557:
Sex: U
Vaccine: VARZOS
Symptoms: Optic ischaemic neuropathy, Vision blurred
Clinical narrative: Bilateral Ischemic Optic Neuropathy; Blurred Vision; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 12-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date (reported as shortly after received zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered vision problems and was diagnosed with blurred vision and bilateral ischemic optic neuropathy. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations did not present prior to used vaccine. The patient also experiences mental and emotional distress due to resulted physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries (disability). Further, as a tragic consequence, and 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. The patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of optic ischaemic neuropathy and vision blurred were not recovered. The reporter considered optic ischaemic neuropathy and vision blurred to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, optic ischaemic neuropathy was considered to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vision blurred, Vitreous floaters
Clinical narrative: Herpes Zoster Ophthalmicus; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 06-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date (reported as shortly after received zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered blurry vision, floaters, and was diagnosed with herpes zoster ophthalmicus. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations did not present prior to used vaccine. The patient also experiences mental and emotional distress due to resulted physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries (disability). Further, as a tragic consequence, and 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. The patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of ophthalmic herpes zoster was not recovered. The reporter considered ophthalmic herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster was considered to be a medically significant event.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; Incorrect product storage; This spontaneous report was received from a medical assisstant and refers to a 4-years-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-JUN-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen and route of administration were not reported), lot numbers reported to suffer temperature excursion were T014388, T025221 (rHA) and T027115 (rHA) and respective expiration dates 24-OCT-2021, 19-JAN-2022 and 02-FEB-2022 (It was not specified which lot was administered to the patient) administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion unknown by the reporter for an unknown timeframe; it was also unknown if there were previous temperature excursions.  No adverse symptoms were reported.  This one of several cases from the same reporter.; Sender's Comments:  US-009507513-2107USA001665: US-009507513-2106USA007465:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Completed suicide, Death, Myelitis transverse, Paralysis
Clinical narrative: died by taking his own life; transverse myelitis; paralysis; This spontaneous report was received from an office manager via company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  Several years ago, the patient was vaccinated with the third dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported; unidentified Merck hpv vaccine administered (name and lot number not provided)). It wasn't sure which was the suspect product.   On an unknown date, the patient developed transverse myelitis, paralysis, and died by taking his own life (completed suicide) after getting the vaccination. This case had been brought to a trial and settled and published in unspecified news article and this case was being associated with legal. Legal issue involved-AE sent to legal. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed. The cause of completed suicide was unspecified. It was unknown if autopsy was done. Outcome of the events transverse myelitis and paralysis was unknown.  The causality between the suspect products and the events was not reported.  Upon internal review, transverse myelitis, paralysis, and died by taking his own life (completed suicide) were determined to be medically significant.; Reported Cause(s) of Death: died by taking his own life
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: a patient missed a dose in her GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history 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) (strength, dose, frequency, route of administration, indication, lot #, and expiration date were not reported) for prophylaxis. On an unknown date, she missed a dose in her HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination schedule (inappropriate schedule of vaccine administered). No adverse event was reported.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy
Clinical narrative: miscarriage; Maternal exposure before pregnancy/separate pregnancy after the miscarriage; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, the patient became pregnant and had a miscarriage. It was verified that the vaccine was administered before the pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was a spontaneous abortion. The patient sough medical attention. It was unknown by the reporter if any treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the event was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the event was not reported.  Upon internal review, the event miscarriage was determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA005773: US-009507513-2107USA006557:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bed rest, Foetal death, Intrapartum haemorrhage, Maternal exposure before pregnancy, Transfusion
Clinical narrative: During labor, the patient lost a lot of blood and had to have blood transfusions; She had to have "one of the twins removed."; bed rest; Maternal exposure before pregnancy/separate pregnancy after the miscarriage; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, during a separate pregnancy after a miscarriage, the patient was due to have twins. It was verified that the vaccine was administered before the pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. During that pregnancy, the patient was on bed rest. On an unknown date, during labor, the patient lost a lot of blood (intrapartum haemorrhage) and had to have blood transfusions. The pregnancy outcome for the first twin was unknown and for the second it was reported that she had to have "one of the twins removed" (foetal death). The patient sough medical attention. It was unknown by the reporter if any other treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the events was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events was not reported.  Upon internal review, the events "during labor, the patient lost a lot of blood" and "she had to have "one of the twins removed"" were determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA006556: US-009507513-2107USA005773:
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: consumer explained that she out of the country right now and will not be back in time to receive her thirds dose; consumer explained that she out of the country right now and will not be back in time to receive her thirds dose; she is not experiencing any side effects/No adverse event or product complaint reported; she received her first dose in January and her second dose May 16, 2021; This spontaneous report as received from a consumer refers to a 17-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  It was reported that in January 2021, but she could not remember the date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On 16-MAY-2021, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The consumer explained that she out of the country right now, and she would not be back in time to receive her thirds dose. The caller stated she was not experiencing any side effects. Also, the caller stated she could not remember the name of the physician that administered her vaccine. The consumer did not give permission for further contact. No adverse event or product complaint reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood test abnormal, Culture stool positive, Dehydration, Rotavirus infection, Rotavirus test positive
Clinical narrative: diagnosed with rotavirus; acutely dehydrated; significant weight loss; This spontaneous report was received from a social worker (registered nurse) concerning to a 3 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. He had not known drug allergies.   On 24-JUN-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, administered orally (frequency, lot# and expiration date were not provided) for prevention of rotavirus gastroenteritis.   On 19-JUL-2021, the patient was diagnosed with rotavirus through blood works and a stool sample. He arrived at the hospital acutely dehydrated and had significant weight loss. The health care professional (HCP) admitted the patient into the hospital to receive support with fluids and a partial immune evaluation. At the time of the report, the patient was recovering from the events.   The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Weight decreased
Clinical narrative: diagnosed with rotavirus; acutely dehydrated; significant weight loss; This spontaneous report was received from a social worker (registered nurse) concerning to a 3 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. He had not known drug allergies.   On 24-JUN-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, administered orally (frequency, lot# and expiration date were not provided) for prevention of rotavirus gastroenteritis.   On 19-JUL-2021, the patient was diagnosed with rotavirus through blood works and a stool sample. He arrived at the hospital acutely dehydrated and had significant weight loss. The health care professional (HCP) admitted the patient into the hospital to receive support with fluids and a partial immune evaluation. At the time of the report, the patient was recovering from the events.   The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; expired dose of PNEUMOVAX 23 was administered to 3 patients; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired vaccine used). There was no additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: at the injection site and below the injection site became extremely red and swollen; at the injection site and below the injection site became extremely red and swollen; This spontaneous report was received from an office manager via company representative and refers to a female patient of an unknown age (reported as "in her 70s"). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in July 2021 (reported as "within the last 3-5 days"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T033663, expiration date 21-MAR-2022 (dose, route of administration and anatomical location was not reported) for prophylaxis. On an unknown date in July 2021, the patient's vaccination site and below the vaccination site became extremely red and swollen. The physician thought there might have been a blood clot. On an unknown date in July 2021, an ultrasound was performed but nothing was found. It was reported that the patient sought medical attention. The outcome of the events was reported as recovering.  Causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033663; expirationdate: 21-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: Product temperature excursion issue
Clinical narrative: VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant referring to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 20-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T035400 with an expiration date on 16-OCT-2022) after undergoing a temperature excursión of +0.4°C Celsius degrees for 13 hours and 10 minutes recorded by a data logger. The suspect vaccine was indicated for prophylaxis (product storage error).       No previous temperature excursions were reported.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: muscle soreness at site of injection; Pneumococcal vaccine administered in 2016 and 2017; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS 2101USA007844), concerning to a 65-year-old male patient. The patient's concurrent condition, medical history and concomitant medications were unknown.  In 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown); then, in 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, anatomical site of vaccination and lot number with expiration date were not provided) for prophylaxis (inappropriate schedule of product administration).  Then, on an unknown date, the patient experienced muscle soreness at site of injection (vaccination site pain).      The outcome of vaccination site pain was unknown.     The reporter considered vaccination site pain to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).; Sender's Comments:  US-009507513-2101USA007844:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy; Fatigue / tired; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a month after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced sleepiness. In June 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received Shingrix vaccine and experienced fatigue, felt very tired and less than 6 months after receiving Shingrix, was sleepy. The batch number for Shingrix was unknown. The reporter and healthcare professional (physician) consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR156342, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156342:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shot 12 months after the second shot; This case was reported by a consumer via media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received shot, 12 months after 2nd dose, which led to extra dose administered. The reporter asked, was this sequence still effective.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Dose 1/7/21, second dose 4/21/21. They then noticed that he had received a first dose / on 10/15/18; Second dose 4/21/21 / Then noticed / a first dose / on 10/15/18; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th October 2018).   On 7th January 2021, the patient received the 2nd dose of Shingrix. In April 2021, the patient received the 3rd dose of Shingrix. On 7th January 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient had received first dose of Shingrix at their clinic on 7th January 2021 and then noticed that he had received a first dose of Shingrix on 15th October 2018 at another location outside their network which led to lengthening of vaccination schedule. On 21st April 2021 patient reported that received second dose of Shingrix which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix and experienced muscle pain and fever . The patient enquired how long does the side effect last. No other information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got / vaccination Tuesday / seems to be having a new shingles breakout; This case was reported by a consumer via media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. The patient had got her shingles vaccination on Tuesday and developed a new shingles breakout.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 / on :8 march 2019 dint get 2nd dose / Hcp also believes the wife may have also but unsure; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter believed that the patient might had not received 2nd dose of Shingrix but was unsure.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up. This case had been linked with US2021153984, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021153984:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles / Believe me its hell.; got shingles after 3 years after my first round of shots / when the one came out for seniors I ran to get those; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving 1st round of Shingles vaccine, the patient got shingles. The patient stated that, when the one came out for seniors, he/she ran out to get those which led to extra dose administered. He/she reported that, they said they were much better and stated that, it was worth every penny not to go through that again. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Overdose, Pruritus, Somnolence
Clinical narrative: had the shot to prevent the Shingles / had the Shingles.it was Hell.n it was almost two solid months; my back was just burning / some time it will burn; some time it will / itch; couldn t wake up till noon ..drinking several cups of cafene coffee; had the Shingles.it was Hell.n it was almost two solid months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and hard to awaken. The patient was treated with coconut oil, naproxen (Aleve) and ibuprofen. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus and hard to awaken were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and hard to awaken to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine and 30th November patient back was just burning and patient Shingles.it was Hell and it was almost two solid months. after some time it will burn and itch. The patient found coconut oil relieves it the best. It's been quite a year the medical field just want to prescribed capenpendan patient took it bonce and  couldn't t wake up till noon. The patient drinking several cups of caffeine coffee and refused and over dosed on Aleve n ibuprofen. The patient kept track and wrote if down when and  how much he/her took. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: had the shot to prevent the Shingles / had the Shingles.it was Hell.n it was almost two solid months; my back was just burning / some time it will burn; some time it will / itch; couldn t wake up till noon ..drinking several cups of cafene coffee; had the Shingles.it was Hell.n it was almost two solid months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, pruritus and hard to awaken. The patient was treated with coconut oil, naproxen (Aleve) and ibuprofen. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus and hard to awaken were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and hard to awaken to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine and 30th November patient back was just burning and patient Shingles.it was Hell and it was almost two solid months. after some time it will burn and itch. The patient found coconut oil relieves it the best. It's been quite a year the medical field just want to prescribed capenpendan patient took it bonce and  couldn't t wake up till noon. The patient drinking several cups of caffeine coffee and refused and over dosed on Aleve n ibuprofen. The patient kept track and wrote if down when and  how much he/her took. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got my first shingle shot on the 24th of June and now I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient reported that, he or she received the Shingles vaccine on 24th June and now had a shingles. No further information was reported.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: Fatigue / tired; sleepy; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose in January 2021 and experienced tiredness and sleepiness, refer case- US2021151991).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a month after receiving Shingrix, the patient experienced fatigue and sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had Shingrix vaccine in June 2021 and experienced fatigue, felt very tired and sleepy. The batch number for Shingrix was unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151991:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still got shingles/Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced shingles. The reporter stated it cannot be prevented and was told it was not as bad as if not had the shot. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.