chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Pityriasis rosea, Rash, Rash pruritic, Skin exfoliation, Skin warm
Clinical narrative: he broke out in a rash and it was diagnosed by the pediatrician as Pityriasis rosea; This spontaneous report was received from a consumer(mother of a patient, who was also a clinical research coordinator) and refers to a 12-year-old male patient. The patient was asthmatic and his concomitant therapy included fluticasone propionate (FLONASE). The patient's drugs reactions or allergies were not provided.  On unspecified date in 2020, 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 provided) as a prophylaxis. On 11-NOV-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), intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. On the same day, within 12 hours, he"broke out in a rash" and it was diagnosed by the pediatrician as pityriasis rosea. Mother reported that the rash started on her sons stomach and has spread to his face down to his calves. She reported that the rash was diffuse, warm, itchy and "sloughing off'. One week after the start of the rash, the patient was seen by the allergist, who also diagnosed with pityriasis rosea and treatment has been topical steroid. Mother reported that in some areas the rash was resolving, some areas the rash has "dimmed" and other areas were still "lit up". The pityriasis rosea was ongoing at the time of report.  The causal relationship between pityriasis rosea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Product dose omission issue
Clinical narrative: Pharmacist reported a missed dose for the GARDASIL 9 3-dose regimen; This spontaneous report was received from a pharmacist and refers to a 26 -year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On unspecified date in October 2019, 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) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The pharmacist reported a missed dose for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 3-dose regimen. The pharmacist stated, that the patient has still not received the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) per the prescribing information schedule.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: the patient bad not reported any adverse effects from Intramuscular administration; MMR ll vaccine intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist referring to a 64 years old female patient. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not provided.      On 04-DEC-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength and dose were not provided; lot # was S032826 and expiration date was 16-OCT-2021) intramuscularly for prophylaxis (incorrect route of product administration). At the time of this report, the patient bad not reported any adverse effects from intramuscular administration but the patient also had not been notified she received the vaccine intramuscularly instead of subcutaneously.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: GARSASIL 9 at 14 years old in July 2109, turned 15 in May of 2020; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date in July 2019, at the age of 14 years old, the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, (route of administration, lot #and expiration date were not provided) for prophylaxis. On unspecified date in June 2020, at the age of 15 years old,  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) 0.5 ml (route of administration, lot #and expiration date were not provided) for prophylaxis. She wanted to know if this complete the series. The onset date of the inappropriate schedule of product administration was reported as 08-DEC-2020 and the outcome was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: received an expired MMRII; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided.   On 03-DEC-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 ml (dose, route of administration and anatomical site of vaccination were not reported, lot #R028225, expiration date reported and validated as 02-OCT-2020) for prophylaxis (expired product administered). The outcome of expired product administered was unknown.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: temperature excursion, temperature: 8.3C, time frame: 12 minutes; This spontaneous report was received from a registered nurse referring to 10 unspecified patients of unknown age or gender.  The patients' concurrent conditions, medical history and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (doses, frequencies, routes, lot#s and expirations dates were not reported). The reporter said that the product had undergone temperature excursion at 8.3°C, with a time frame of 12 minutes, digital data logger: "yes". There were no previous temperature excursions.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired GARDASIL 9 was administered to patient; This spontaneous report has been received from an medical assistant and consumer referring to a patient of unknown age and unknown gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was unknown.  On 09-DEC-2020, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (formulation: vial, intramuscular (IM), lot # R009614, expiration date 30-NOV-2020) for prophylaxis (Expired product administered) and was inquiring of vaccine was still viable. There was no additional adverse event reported.  This is a non-valid case due to no patient's identifier.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: An expired PROQUAD (lot S017265 exp 12/1/2020) was administered to one patient on 12/10/2020; No additional adverse events reported; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-DEC-2020, the patient was vaccinated with dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) injection, subcutaneously, lot # S017265, expiration date 01-DEC-2020 (strength and dose were not reported) reconstituted in properly stored and not expired sterile diluent for prophylaxis. No additional adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported.; a 5 year old patient received 2 pediatrie doses of VAQTA on one visit; This spontaneous report was received from an office manager and refers to a 5 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 11-DEC-2020, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, 25/0.5 (units not provided) lot # S037576, expiration date 10-APR-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis at one visit (inappropriate schedule of product administration). It was just human error and not product confusion. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Facial paralysis, Post herpetic neuralgia, Trigeminal neuralgia, Visual impairment
Clinical narrative: facial paralysis; congestive heart failure; postherpetic neuralgia; vision problems; trigeminal neuralgia; Information has been received from a lawyer and a currently 67 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently (date not reported), the patient was treated by a provider for postherpetic neuralgia, vision problems, facial paralysis, congestive heart failure and trigeminal neuralgia. The patient claimed following damages as a result of zoster vaccine live (ZOSTAVAX): injury to themselves and economic losses. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related.   Upon internal review, the events of facial paralysis and cardiac failure congestive were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      In or about 2012, the patient was administered zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by various healthcare providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown. The reporter considered events to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 87-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On or about 14-APR-2015, the patient was administered zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated for the following injuries resulting from zoster vaccine live(ZOSTAVAX) use: shingles. The outcome of the event was unknown. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Acute respiratory failure, Bone pain, Pyrexia
Clinical narrative: Acute Lung Failure; pain in her bones; Zostavax administered on 08-MAY-2019 and 07-JUL-2019; This spontaneous report has been received from a lawyer and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 08-MAY-2019, the patient was inoculated with the first dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On or around 07-JUL-2019, the patient was inoculated with the second dose of zoster vaccine live (ZOSTAVAX). On an unknown date, shortly after receiving the second dose of zoster vaccine live (ZOSTAVAX), the patient suffered pain in her bones and developed a fever that caused her to be admitted in the emergency room. On an unknown date, she was diagnosed with acute lung failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms 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 of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of acute lung failure was determined to be medically significant.  The events were considered to be disabling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: She didn't have a bad reaction to it.; This year she took both of the shingles vaccines. 24Jan2020 she took the first shingles vaccine and then on 25Mar2020 the second shingles vaccines.; This spontaneous report was received from 71-year-old female patient, who was referring to herself. The patient's concurrent conditions included pressure headaches from storms, melanoma (found in December 2003), thyroid disorder and diabetes. Concomitant therapies included levothyroxine sodium (SYNTHROID), colesevelam hydrochloride and metformin hydrochloride. She was divorced. The patient was allergic to pollen from every tree except cottonwood, to every pain medication in the world (codeine, morphine, ibuprofen, naproxen (reported as "naproysyn"), acetaminophen, sulindac (CLINORIL), tramadol, anaphylaxis to opioids; she was able take aspirin - she limited herself to 6 tablets per year), also allergic to fluoride, synthetic tetanus, band aid adhesive and sulfa drugs, to night shade family (tomatoes, eggplant, potatoes and bell peppers; bell pepper and egg plant caused anaphylaxis to her; she could walk into the produce department and the oil got in the air from a bell pepper and she would start having a reaction), tobacco, ants, bees and wasps and insect bites (she got anaphylaxis if she got stung by ants, bees, wasp and insect bites), carbon paper, cleaning chemicals, dust, eucalyptus (the scent of it in the air caused her eyes to start swelling; she has not been able to wear make up), mold, pesticides, smoke, synthetic fabrics (like polyester) and synthetic perfumes, tree sap (the saps from Evergreen and tropical varieties of plants, like palm trees, caused rashing). She could eat eggs and was not allergic to eggs. She could eat tree nuts like pecans and walnuts, yet she was allergic to the pollen from the tree. On an unknown date in September 1967 (reported as in the fall of 1967), she received her first flu vaccine. She had the flu vaccine again the next year in 1968. She had a big goose egg, rashing, and problems breathing. She had a reaction again. She has never had another flu vaccine and has not had the flu either. On an unknown date in approximately 2012 (8 years ago, also reported as the last time), she had an opioid, which was from a dentist. He said she would not be allergic to it. She believed him and took it. In less than 15 minutes, she was projectile vomiting into the toilet. Those are some of her symptoms.   On 24-JAN-2020, the patient was vaccinated with the first dose of a shingles vaccine (manufacturer unknown) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis. On 25-MAR-2020, the patient received the second dose of shingles vaccine (manufacturer unknown). The patient did not had any bad reaction to the vaccines.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-2012USA004558:
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: after receiving the PNEUMOVAX 23 vaccine she experience chills and slight fever for a day or two; after receiving the PNEUMOVAX 23  vaccine she experience chills and slight fever for a day or two; This spontaneous report was received from a female consumer of unknow age referring to herself. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 14-NOV-2020 (reported as last Monday),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as prophylaxis (concentration, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).     On 14-NOV-2020, the patient experienced chills and slight fever (pyrexia) for a day or two.  The patient recovered from the events on an unspecified date in November 2020.  The causality assessment between the suspect product and the aforementioned events was not provided.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: anaphylactic reaction; Information has been received from a physical assistant who was also the patient's mother referring to a 9 months old (also reported as 10 months old) female patient. The patient's pertinent medical history included food allergies (sesame, egg, cow milk, peanuts). She had anaphylactic reaction to food once. The patient's historical vaccines included hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) (reported as "Emgcrix B") and an unknown non-company hepatitis B vaccine (the patient did not have reactions to both doses). The patient did not have concomitant medication.  On 07-DEC-2020 in the evening, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (0.5 ml x 1 dose, intramuscular; lot number and expiration date were not provided; reported as the third dose in series of hepatitis B vaccine; therapy type was not specified) for prevention of hepatitis B at her pediatrician's office.   On the same day at night, the patient went to bed and woke up with hives which progressed into an anaphylactic reaction over a 16-hour time frame. The patient was given an epinephrine hydrochloride (EPIPEN) by the reporter which they had at home due to the patient having multiple allergies. The patient was then taken to the hospital for medical attention and monitored overnight. Other treatment for the event included diphenhydramine hydrochloride (BENADRYL). No lab diagnostics or studies were performed. On 12-DEC-2020 (also reported as after 5 days of rash), the patient was fully recovered. The reporter stated that this was the only hepatitis b vaccine (recombinant)(RECOMBIVAX HB) the patient received. No product quality complaint (PQC) was reported. The vaccine was not available for retrieval as it was disposed of after administration at doctor's office. The causality assessment was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant. According to the reporter, the event was considered serious because of intervention to prevent serious criteria, significant disability or incapacity, life threatening and hospitalization.
Sex: M
Vaccine: VARZOS
Symptoms: Acute sinusitis, Asthenia, Balance disorder, Blindness unilateral, Bronchitis
Clinical narrative: pneumonia; vertigo optic neuritis; ischemic optic neuropathy; OTITIS MEDIA; acute labyrinthitis; acute sinusitis; acute bronchitis; nuclear sclerosis; vertigo optic neuritis; 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. On or around August 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered various injuries, including, but not limited to, a lung infection, hearing problems, vision problems, loss of balance and weakness. As a result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with otitis media, acute labyrinthitis, acute sinusitis, acute bronchitis, pneumonia, vertigo optic neuritis, nuclear sclerosis, and ischemic optic neuropathy. The patient had undergone extensive medical treatment and suffered from blindness in his left eye. 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, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 the events was considered not recovered/not resolved. The reporter considered all the events were related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disability.   Upon internal review, pneumonia, optic neuritis and optic ischaemic neuropathy were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cataract nuclear, Hypoacusis, Labyrinthitis, Optic ischaemic neuropathy, Optic neuritis
Clinical narrative: pneumonia; vertigo optic neuritis; ischemic optic neuropathy; OTITIS MEDIA; acute labyrinthitis; acute sinusitis; acute bronchitis; nuclear sclerosis; vertigo optic neuritis; 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. On or around August 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered various injuries, including, but not limited to, a lung infection, hearing problems, vision problems, loss of balance and weakness. As a result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with otitis media, acute labyrinthitis, acute sinusitis, acute bronchitis, pneumonia, vertigo optic neuritis, nuclear sclerosis, and ischemic optic neuropathy. The patient had undergone extensive medical treatment and suffered from blindness in his left eye. 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, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 the events was considered not recovered/not resolved. The reporter considered all the events were related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disability.   Upon internal review, pneumonia, optic neuritis and optic ischaemic neuropathy were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Otitis media, Pneumonia, Vertigo, Visual impairment
Clinical narrative: pneumonia; vertigo optic neuritis; ischemic optic neuropathy; OTITIS MEDIA; acute labyrinthitis; acute sinusitis; acute bronchitis; nuclear sclerosis; vertigo optic neuritis; 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. On or around August 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered various injuries, including, but not limited to, a lung infection, hearing problems, vision problems, loss of balance and weakness. As a result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with otitis media, acute labyrinthitis, acute sinusitis, acute bronchitis, pneumonia, vertigo optic neuritis, nuclear sclerosis, and ischemic optic neuropathy. The patient had undergone extensive medical treatment and suffered from blindness in his left eye. 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, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 the events was considered not recovered/not resolved. The reporter considered all the events were related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disability.   Upon internal review, pneumonia, optic neuritis and optic ischaemic neuropathy were considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE; customer reporting administration of expired Gardasil 9; Information has been received from the pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant therapies were not provided.   On 09-DEC-2020, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, and lot number were not provided), which expired on 07-DEC-2020 (expired product administered), for prophylaxis. No adverse event was reported.
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Therapeutic response changed
Clinical narrative: her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; her daughter's blood titers were drawn on 12/14/2020 and showed "non-reactive" for V ARIV AX, RECOMBIV AX, and MMR II.; This spontaneous report was received from a physician and refers to a currently 19-year-old female patient. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported), all for immunization. On 14-DEC-2020, the patient's blood titers were drawn and showed "non-reactive" for varicella virus vaccine live (oka/merck)(VARIVAX), hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). On an unknown date, the patient sought medical attention (she saw a physician). No treatment was given to the patient. The outcome of the events was not provided. The causality assessment between the events and the suspect therapies was not reported.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender.  On an unknown date in September 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a physician for the following injury, resulting from zoster vaccine live (ZOSTAVAX) vaccination: shingles.  The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; My wife gets them / Then still gets some sort of flu; My wife gets them and.is sick as a dog every year.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine and was sick as dog every year. After that the patient had some sort of flu. It was reported, It was all about the money follow the money read and look up all the ingredients on the box then decide if want that junk in your body. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation, Skin warm
Clinical narrative: Left arm was red; Left arm was red, irritated, and warm to touch; Left arm was red, irritated; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities, skin warm and skin irritation. On an unknown date, the outcome of the erythema of extremities, skin warm and skin irritation were unknown.   It was unknown if the reporter considered the erythema of extremities, skin warm and skin irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and reporter reported after the vaccination, the left arm was red, irritated and warm to touch. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: fatigue; pain at injection; Chills; low grade fever; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, injection site pain, chills and fever. On an unknown date, the outcome of the fatigue, injection site pain, chills and fever were unknown.   It was unknown if the reporter considered the fatigue, injection site pain, chills and fever to be related to Shingrix.  Additional details were received as follows: The age at the vaccination was not applicable for this report. There are many patients have side effects from the Shingrix vaccine that were more common than many other vaccines. The reporter got that and still encourage the patients to get the vaccine. But significant enough that patients were sometimes nervous about the 2nd injection.  The usual side effects were fatigue, pain at injection site, chills, some grade fever. HCP did not have any patient specifics or vaccine details. The reporter was inquiring if the side effects were less severe with the 2nd dose as opposed to the 1st dose. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination
Clinical narrative: About a year since the first dose; Really sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female 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 (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. The reporter also mentioned she was really sick for 4 days after receiving the first dose in the arm. The reporter was asking if it was okay for her to get the second dose of Shingrix if it had been about a year since the first dose, which led to incomplete course of vaccination. Spoke per content and CDC recommendations to receive second dose as soon as possible and there is no need to restart the series.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get the flu everytime I get the shot; Based on information received on 14-Dewc-2020 case updated as valid case.  Initial information received on 09-Oct-2020 regarding an unsolicited non-serious non-case received from a consumer(Patient) via social media.  This case involves a patient of unknown demography who got the flu everytime (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient received INFLUENZA VACCINE and got the flu everytime (influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  Additional information received on 14-Dec-2020 regarding an unsolicited non-serious case received from a consumer(Patient) via social media.  Event (influenza) was added; Corresponding fields and narrative updated accordingly.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: i get sick every year with flu shot; Based on additional information received on 20-Oct-2020, the case was updated from non case to a valid non serious case due to addition of adverse event sickness with the suspect vaccine.  Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media.  This case is linked to cases 2020SA297294, 2020SA297267 and 2020SA273251 (cluster).  This case involves a 83 years old patient of unknown gender who reported that i get sick every year with flu shot (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route at an unknown administration site (lot number and expiry date not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) the patient stated that he/she got sick every year with flu shot (illness), the doctor knew it and he/she had to go somewhere with others for 24hrs and could not have the above 65 one.   No laboratory data was reported.  Corrective treatment and event outcome were unknown.  There will be no information available on batch number for the case.  Additional information regarding the valid non-serious case was received on 20-Oct-2020: The case was updated to valid non serious due to addition of event sickness. Corresponding fields and narrative were updated accordingly.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: flu; got sick as fuck; Based on additional information received on 22-Oct-2020, the case was initially considered as non valid was updated to valid case due to addition of influenza vaccine as the suspect product.  Initial information regarding an unsolicited non-valid non-serious case received from a consumer (patient) via social media and was transmitted to Sanofi on 28-Sep-2020.  This case was linked to case 2020SA295897, 2020SA299080, 2020SA299167, 2020SA299168, 2020SA299171, 2020SA299170, 2020SA299169 (cluster).  This case involves a patient of unknown demographics who had flu (Influenza) and got sick (Malaise), while the patient received INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date (reported as two years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route at an unknown administration site (lot number and expiry date not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) the patient developed a non-serious flu (influenza) and got really sick (illness) following administration of INFLUENZA VACCINE .  No laboratory data was reported.  Corrective treatment and event outcome were unknown.  There will be no information available on batch number for the case.  Additional information regarding the valid non-serious case was received on 22-Oct-2020 from a consumer (patient) via social media.  Case was updated to valid due to addition of influenza vaccine as the suspect. Event flu was added. Action taken, as reported term of event sickness and company causality were amended from the previous version. Corresponding fields and narrative were updated accordingly.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: got the worst flu of my life; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious social media case  from a consumer (patient).  This case is linked to case 2020SA296074.  This case involves a patient of unknown demographics, who reported got the worst flu of my life (influenza), while he/she received vaccine influenza quadrival a-b multidose vaccine preserved (Fluzone).  The patient's medical history, medical treatments, vaccinations, condition medications and family history were not provided.  On an unknown date, the patient received influenza vaccine (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient stated got the worst flu of my life (influenza, that patient hot the shot since would be with kids. Now patient was older and had immune problems so patient definitely get it.  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for flu.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurses administered 9 shots, at least 8 were to patients under the age indication.; Initial information regarding an unsolicited valid non-serious case received from other health professional on 22-Oct-2020.  This case involves patients of unknown demographics who were administered 9 shots, at least 8 were to patients under the age indication (product administered to patient of inappropriate age), while he/she received vaccine INFLUENZA VACCINE.  Concomitant medications were unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route at an unknown administration site (lot number: UT7081NA and expiry date: 30-Jun-2021) for prophylactic vaccination.  On an unknown date, (unknown latency) it was stated that the nurses administered 9 shots, at least 8 were to patients under the age indication (product administered to patient of inappropriate age).  It was not reported if the patient received a corrective treatment.  There will be no information available on batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get a serious case of the flu; Initial information regarding an unsolicited valid serious case received from a consumer (patient) via social media on 27-Oct-2020.  This case is linked to case 2020SA305230. (Same reporter media)  This case involves a patient of unknown demographics who got a serious case of the flu (Influenza), while patient received INFLUENZA VACCINE.  Past vaccination included flu shot (INFLUENZA VACCINE) which did not contain the strain H1N1.  Medical history, medical treatment, family history and concomitant medication were not provided.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date unknown) not reported via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed serious case of the flu (Influenza) (unknown latency) after the administration of INFLUENZA VACCINE. As a reason of developing the flu, the patient explained that the last flu that was received did not contain the strain H1N1 which was there in the current INFLUENZA VACCCINE that was received. Thee patient also said that even if the new strain had been added to the current INFLUENZA VACCCINE, the patient was always immuned to the older strains and that she highly recommended of getting the flu shot as it helps the symptoms to keep milder.   The event flu was assessed as medically significant as per reporter.   No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information on the batch number for this case.; Sender's Comments: Sanofi company comment dated 18-Dec-2020: This case concerns a patient of unknown demographics who had presented Influenza after vaccination with company suspect INFLUENZA VACCINE. The time to onset was unknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Moreover, one vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.