chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Full body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 10th January 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 20th July 2019, 191 days after receiving Shingrix, the patient experienced generalized rash. The patient was treated with prednisone and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient developed a full body rash which was still continuing. He had been through 4 cycles of prednisone and creams and the rash keeps returning. The reporter did not consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Full body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 10th January 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 20th July 2019, 191 days after receiving Shingrix, the patient experienced generalized rash. The patient was treated with prednisone and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient developed a full body rash which was still continuing. He had been through 4 cycles of prednisone and creams and the rash keeps returning. The reporter did not consented to follow up.
Age: 57.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: injection site discomfort; fever; chills; myalgia; felt like influenza; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 57-year-old patient 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 injection site discomfort, fever, chills, myalgia and influenza like illness. On an unknown date, the outcome of the injection site discomfort was unknown and the outcome of the fever, chills, myalgia and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort, fever, chills, myalgia and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed significant fever, chills, and myalgia lasting 24 hours felt like influenza as well as injection site discomfort.
Age: 57.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site discomfort, Myalgia, Pyrexia
Clinical narrative: injection site discomfort; fever; chills; myalgia; felt like influenza; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 57-year-old patient 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 injection site discomfort, fever, chills, myalgia and influenza like illness. On an unknown date, the outcome of the injection site discomfort was unknown and the outcome of the fever, chills, myalgia and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort, fever, chills, myalgia and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed significant fever, chills, and myalgia lasting 24 hours felt like influenza as well as injection site discomfort.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (for tolerance refer case US2019AMR211802).   On 12th November 2019, the patient received the 2nd dose of Shingrix. On 13th November 2019, 1 days after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported that the patient had nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day after receiving 2nd dose Shingrix. The patient had had the same reaction the first time but did not describe first dose reactions. The physician prescribed medication for nausea for the patient. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Feeling abnormal, Malaise, Nausea
Clinical narrative: Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (for tolerance refer case US2019AMR211802).   On 12th November 2019, the patient received the 2nd dose of Shingrix. On 13th November 2019, 1 days after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported that the patient had nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day after receiving 2nd dose Shingrix. The patient had had the same reaction the first time but did not describe first dose reactions. The physician prescribed medication for nausea for the patient. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (for tolerance refer case US2019AMR211802).   On 12th November 2019, the patient received the 2nd dose of Shingrix. On 13th November 2019, 1 days after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported that the patient had nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day after receiving 2nd dose Shingrix. The patient had had the same reaction the first time but did not describe first dose reactions. The physician prescribed medication for nausea for the patient. The reporter consented to follow up.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Muscle twitching, Myalgia
Clinical narrative: Cellulitis of staph infection; muscle twitch; This spontaneous report was received from a pharmacist regarding a 69 years old female patient. Patient had no pertinent medical history, drug reactions/allergies and concomitant medications. 14-NOV-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot# R011632 with expiry date of 02-FEB-2020, intramuscular for prophylaxis (dose not reported). On 15-NOV-2019, the patient developed muscle twitch, pain, tenderness, swelling on the left arm from the shoulder pass to the elbow. On 16-NOV-2019, the patient went to the physician's office where she was diagnosed with cellulitis of staph infection. Patient sought medical attention by seeing the physician and received sulfamethoxazole, trimethoprim (BACTRIM) as treatment for the event. Patient did not undergo any laboratory/diagnostic tests. Outcome of the events were reported as recovering. Causality of the events were not reported.   Upon internal review, the event "Cellulitis staphylococcal" was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Staphylococcal infection
Clinical narrative: Cellulitis of staph infection; muscle twitch; This spontaneous report was received from a pharmacist regarding a 69 years old female patient. Patient had no pertinent medical history, drug reactions/allergies and concomitant medications. 14-NOV-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot# R011632 with expiry date of 02-FEB-2020, intramuscular for prophylaxis (dose not reported). On 15-NOV-2019, the patient developed muscle twitch, pain, tenderness, swelling on the left arm from the shoulder pass to the elbow. On 16-NOV-2019, the patient went to the physician's office where she was diagnosed with cellulitis of staph infection. Patient sought medical attention by seeing the physician and received sulfamethoxazole, trimethoprim (BACTRIM) as treatment for the event. Patient did not undergo any laboratory/diagnostic tests. Outcome of the events were reported as recovering. Causality of the events were not reported.   Upon internal review, the event "Cellulitis staphylococcal" was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis staphylococcal, Muscle twitching, Pain, Peripheral swelling, Tenderness
Clinical narrative: Cellulitis of staph infection; muscle twitch; This spontaneous report was received from a pharmacist regarding a 69 years old female patient. Patient had no pertinent medical history, drug reactions/allergies and concomitant medications. 14-NOV-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot# R011632 with expiry date of 02-FEB-2020, intramuscular for prophylaxis (dose not reported). On 15-NOV-2019, the patient developed muscle twitch, pain, tenderness, swelling on the left arm from the shoulder pass to the elbow. On 16-NOV-2019, the patient went to the physician's office where she was diagnosed with cellulitis of staph infection. Patient sought medical attention by seeing the physician and received sulfamethoxazole, trimethoprim (BACTRIM) as treatment for the event. Patient did not undergo any laboratory/diagnostic tests. Outcome of the events were reported as recovering. Causality of the events were not reported.   Upon internal review, the event "Cellulitis staphylococcal" was determined to be medically significant.
Age: 52.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 1st dose of Shingrix .5 ml. On 19th November 2019, less than a day after receiving Shingrix, the patient experienced ringing in ears. The patient was treated with pseudoephedrine hydrochloride (Sudafed). On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced ringing in the ears on the same day of receiving Shingrix. The patient received Sudafed and it helped the patient. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Computerised tomogram abnormal, Injection site reaction, Oedema
Clinical narrative: vaccination 11/29 Admitted 12/1 from ED with cellulitis L deltoid, with deep space fluid collection ?phlegmon on CT
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Blood cholesterol normal, Disturbance in social behaviour, Hepatic enzyme increased
Clinical narrative: The shots appear to have triggered an autoimmune resonse which is still present. Shortly after I received the shots I develped mononucleosis and strep throat. I have been experiencing chronic recurring viral infections since. I have been unable to exercise or perform strenous physical activity, when I do a viral infection manifests. I have had to sleep at least 10 hours each night just to be able to function and get through the day. I have had a difficult time interacting with others and now have a low stress tolerance. I was healthy before the shots and I have felt terrible ever recieving the shots.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Hypersomnia, Infectious mononucleosis, Laboratory test abnormal, Loss of personal independence in daily activities, Mononucleosis heterophile test positive
Clinical narrative: The shots appear to have triggered an autoimmune resonse which is still present. Shortly after I received the shots I develped mononucleosis and strep throat. I have been experiencing chronic recurring viral infections since. I have been unable to exercise or perform strenous physical activity, when I do a viral infection manifests. I have had to sleep at least 10 hours each night just to be able to function and get through the day. I have had a difficult time interacting with others and now have a low stress tolerance. I was healthy before the shots and I have felt terrible ever recieving the shots.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Streptococcal infection, Streptococcus test positive, Viral infection, Vitamin D decreased
Clinical narrative: The shots appear to have triggered an autoimmune resonse which is still present. Shortly after I received the shots I develped mononucleosis and strep throat. I have been experiencing chronic recurring viral infections since. I have been unable to exercise or perform strenous physical activity, when I do a viral infection manifests. I have had to sleep at least 10 hours each night just to be able to function and get through the day. I have had a difficult time interacting with others and now have a low stress tolerance. I was healthy before the shots and I have felt terrible ever recieving the shots.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Headache , slight fever, body aches, diarrhea
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm pain and swelling and redness; (L) upper arm pain and swelling and redness; (L) upper arm pain and swelling and redness; Information has been received from Food and Drug Administration (FDA) (Agency number 804223) under the Freedom of Information Act referring to a 11 years old male patient. Information about medical conditions, allergies and concomitant therapies was not provided (did not have the medical records at the reporting time).      On 26-FEB-2019 at 08:26, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# R019469 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-APR-2021; strength, dose, frequency and route were not reported) in the right arm for prophylaxis. On the same time, he was also vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot # reported as U6153AA; strength, dose, frequency, route and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (lot # reported as 33T42; strength, dose, frequency, route and expiration date were not reported) both in left arm for prophylaxis.     On 01-MAR-2019, the patient experienced left (L) upper arm pain and swelling and redness. There's no relevant diagnostic tests or laboratory data. The outcome of all events was reported as recovered (date unknown in 2019).   The causality between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information has been received from a physician on 30-OCT-2019. The reporter could not identify the patient with no date of birth (DOB).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored MMR II was inadvertenly administered to the patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot # R028003 with expiration date on 01-OCT-2020 (dose and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. The vaccine underwent a temperature excursion of above 47 degrees Fahrenheit (52) for 10 hours. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; the patient received an adult dose of VAQTA instead of pediatric dose of VAQTA; Information has been received from a registered nurse referring to a pediatric patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 08-JUL-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R032910, expiration date: 18-NOV-2019; strength, frequency, route were not reported) for prophylaxis. No adverse effects was reported for the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an unspecified administrator and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 30-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030798 and expiration date: 22-APR-2019 (exact dose, frequency and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported.  The vaccine was stored in between 6 degrees Fahrenheit (F) and 14 F for 420 and in between 15 F to 46 F for 106 hours. There were previous temperature excursions: in between 6 F to 14 F for 200 hours and in between 15 F to 46 F for 18. The improper storage was recorded by Digital Data Logger.; Sender's Comments:  US-009507513-1911USA000877:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: no adverse effects; a patient received a dose of GARDASIL 9 while pregnant; She received her first dose of the series on an unspecified date "in December of 2015"; This spontaneous prospective pregnancy report as received from a nurse refers to a 14-year-old female patient. The patient historical conditions included depression due to desogestrel (+) ethinyl estradiol (APRI) and headaches. Concomitant medication included ethinyl estradiol (+) norgestimate (TRI LO MARZIA) for birth control.  On an unspecified day in December 2015, the patient was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number #1602284, expiration date: 26-SEP-2021) (strength, exact dose and frequency were not reported). On unknown date in 2019, the patient became pregnant with last menstrual period (LMP) of unknown date in September 2019. On 31-OCT-2019, the patient was vaccinated intramuscularly with a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number #1602284, expiration date: 26-SEP-2021) (strength, exact dose and frequency were not reported), while being pregnant (diagnosed by urine pregnancy test on an unspecified day; gestation: 6 weeks and 1 day) (exact start date of the pregnancy and estimated delivery date (EDD) were not provided). No adverse events were reported. The pregnancy outcome was pending and the fetus outcome was unknown at the time of the report.   The relatedness between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported for the patient; administration of one dose of an improperly stored vaccine// Temperature: (58.5 F); administration of one dose of an improperly stored vaccine/ Temperature: (58.5 F)/ possible malfunction of the Data Logger; This spontaneous report has been received from an office manager concerning one patient of unknown age and gender.  The patient's past drug and pertinent medical history, as well as the concomitant medications, were not provided.   On 06-NOV-2019, the patient was vaccinated with one improperly stored dose of 0.5 milliliters (ml) of Hepatitis A Vaccine, Inactivated (VAQTA) as prophylaxis (lot number S009943, expiry date 26-JUL-2020); number of administered dose and frequency of vaccination scheme, route and anatomical location of vaccination were not reported.   The Hepatitis A Vaccine, Inactivated (VAQTA) underwent a temperature excursion of 58.5 degrees Fahrenheit (°F) for a time frame of 10 minutes, as recorded by the data logger. However; the office manager reported a possible malfunction of the data logger (circumstance or information capable of leading to medication error and product storage error). There were not any previous temperature excursions. No adverse effects were reported for the patient.
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: nausea; diarrhea; arm  pain; This spontaneous report was received from a nurse and refers to a 22-year-old female patient with depression and polycystic ovaries. The patient was not pregnant, she had no drug reactions or allergies. Concomitant therapies included birth control pills (unspecified), escitalopram oxalate (LEXAPRO), propranolol and topiramate (TOPAMAX).   On 28-OCT-2019, 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) intramuscularly, expiration date 28-NOV-2021 (exact dose was not reported) (lot number 162196 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) for prophylaxis.  On an unknown date in 2019, after receiving the injection, the patient experienced nausea, diarrhea and arm pain. The nurse reported that "the arm pain continued and was being watched by the patient's primary care provider." There was no treatment given for the adverse events. The patient sought medical attention and called primary care provided.  The outcome of nausea, pain in extremity and diarrhoea was unknown. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects.; Nurse reported lhe patient received a dose ofMMR II (lot number and expiration date unknown by reporter) on 10/24/2009. Nurse reported lhe patient received a dose ofV ARIV AX (lot number and expiration date unknown by reporter) on 11/14/2009.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies were not reported. Concomitant therapies included sterile diluent (DILUENT MRK).  On 24-OCT-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis and on 14-NOV-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (inappropriate schedule of product administration). Information about strength, dose, frequency, route of administration, lot number and expiration date were not provided for both suspected therapies.  No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; inadvertently administered one dose of expired PNEUMOVAX23; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 13-NOV-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength and route were not reported)(lot # R002084, expiration date was 26-OCT-2019) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: patient not experiencing any symptoms; Patient recived second dose, however it was noted the dose had expired; patient was recommended by an unespecified dermatologist to receive GARDASIL 9 to help treat many warts on her feet; 32 year-old patient was recommended by an unespecified dermatologist to receive GARDASIL 9; This spontaneous report was received from a regional director, concerning an approximately 32-year-old female patient of unspecified race. Information regarding her medical history, drug reactions or allergies and concomitant medications was not reported.  In approximately September 2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, frequency, lot number and expiration not reported), administered to treat many (unspecified) warts on her feet, recommended by an unspecified dermatologist (product use in unapproved indication and product administered to patient of inappropriate age). On 15-NOV-2019 (also reported as "today"), the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection (dose, frequency and indication not reported), lot number: R024264, expiration date: 29-OCT-2019, which was noted as an expired dose (expired product administered). The patient was not experiencing any symptoms (no adverse events) and no product quality complaint (PQC) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: 50 year old patient who did not have insurance and was ordered GARDASIL 9; Gardasil for EDV disease; This spontaneous report was received from a nurse via company representative referring to a 50-year-old patient of unknown gender. The patient's concurrent condition included an insurance issue; patient's pertinent medical history, concomitant medications and previous drug reactions or allergies were not provided.   On an unknown date, the patient may have been vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for epidermodysplasia verruciformis (EDV) disease (product administered to patient of inappropriate age and product use in unapproved indication) (strength, dose, scheme of vaccination, route of administration, anatomical location were not reported; lot number and expiration date  were unknown by the reporter).
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; patient was administered the 1st dose of MMR II on 07-NOV-2019 and the 2nd MMR II dose was administered on 13-NOV-2019; This spontaneous report was received from a nurse referring to a 5-year-old, unspecified gender patient. Patient's pertinent historical and concurrent conditions, historical and concomitant medications, drug reactions and allergies were not provided.   On 07-NOV-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On 13-NOV-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number S004118 has been verified to be a valid lot number, expiration date established as 11-FEB-2021) (inappropriate schedule of product administration). In addition, the patient did not experience any adverse effects.
Sex: M
Vaccine: PPV
Symptoms: Food allergy, Malaise, Surgery
Clinical narrative: he got really sick; allergic to eggs; Information was received from a male patient of unknown age concerning himself. The patient used to get bronchitis all the time and by the time he sought treatment the bronchitis would be "minutes away" from being classified as pneumonia on unspecified dates. The patient's concomitant medication and drug reactions/ allergies were not provided.    In approximately 1999 (reported as about twenty years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (every seven years, dose number, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis. The patient been able to avoid getting bronchitis since he began using pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) over twenty years ago.         On an unknown date the patient got really sick, which required an unspecified surgery on an unspecified date and required hospitalization at an unspecified facility. Since that sickness the patient had been allergic to eggs.   The outcome of got sick and allergic to eggs was unknown. The causality assessment was not provided.             This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-1911USA012305:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient received VARIVAX after temperature excursion; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration and anatomical site of vaccination were not reported; lot number reported as R018933, expiration date 02-JUL-2020) as prophylaxis (product storage error). The vaccine had a temperature excursion from 15 degrees Fahrenheit (°F) to 46 °F (34.1 °F) for 4 hours; which was call because of a data logger. As concomitant medication, sterile diluent was used to reconstitute the vaccine, which did not suffer any temperature excursion.   This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA013438:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; a patient received an improperly stored dose of PROQUAD (lot S021325 exp 1/5/2021).; This spontaneous report was received from a medical assistant referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 19-NOV-2019, multiple unknown patients received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (lot # S021325 and expiration date 05-JAN-2021; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent temperature 17.2 Fahrenheit for a duration for 14 hours 30 minutes. There was no previous temperature excursion and data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Concomitant medications included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug allergies or reactions were not reported.     On 20-MAR-2019, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number R020678 and expiration date 15-JAN-2020, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  The administered dose of the vaccine experienced a temperature excursion of 15 °F to 46 °F degrees Fahrenheit for 22 hours, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: The patient had Measles titers drawn and they "came back negative".; Patient did not experience any symptoms; This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were unknown by reporter.       On an unknown date, the patient was vaccinated with full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reporter).         On an unspecified date afterwards, it was performed measles titer drawn test, since the patient expressed concern over recent measles outbreaks, and the result came back negative (measles antibody negative). The patient did not experience any symptoms. She reported was still not recovered as the titers remained negative. It was reported the patient no sought medical attention and any treatment has been provided for the event.  The causality assessment between the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the occurrence of the aforementioned events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: fainted; hit their heads; This spontaneous report was received from a registered nurse via a company representative referring to a 11 or 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     In September 2018, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, lot # and expiration date were not reported) for prophylaxis.  In September 2018(reported as after receiving the dose of the vaccine), the patient fainted in the office and hit her head. On an unknown date, the patient required medical attention from an unspecified hospital. It was unknown if the patient was admitted to the hospital. The patient was still in the doctor's office. The outcome of the events was recovered on an unknown date. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, fainted was determined to be medically significant.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA010728:
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: fainted; hit their heads; This spontaneous report was received from a registered nurse via a company representative referring to a 11 or 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     In September 2018, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, lot # and expiration date were not reported) for prophylaxis.  In September 2018(reported as after receiving the dose of the vaccine), the patient fainted in the office and hit her head. On an unknown date, the patient required medical attention from an unspecified hospital. It was unknown if the patient was admitted to the hospital. The patient was still in the doctor's office. The outcome of the events was recovered on an unknown date. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, fainted was determined to be medically significant.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA010534:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; The patient was administered GARDASIL 9 in a 2 dose regimen series; This spontaneous report was received from a office manager regarding a 22 year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 05-AGU-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 2 dose regimen for prophylaxis (route of administration, lot number, and expiration date was not provided) (inappropriate schedule of product administration). No additional adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I read that PROQUAD vaccine is prescribed for children between 12 months and 12 years. Can it also be used for adults; This spontaneous report was received from a company representative concerning an adult patient of unknown age and gender. No information pertinent medical history, concomitant medications or drug reactions/allergies.     On an unknown date, the patient was vaccinated Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date) (product administered to patient of inappropriate age).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incorrect route of product administration
Clinical narrative: patient received the second dose of GARDASIL subcutaneously. It is unclear if the patient received quadrivalent GARDASIL or GARDASIL 9; This spontaneous report has been received from a consumer, concerning his wife a female patient of unknown age.     The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with the first dose of unidentified Merck hpc vaccine administered intramuscularly into her left arm, and later on unknown date (reported as "two months later"), the second dose of unidentified Merck hpc vaccine was administered subcutaneously (incorrect route of product administration) (lot number and expiration date were not reported) as prophylaxis.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a consumer via a company representative referring to a 18 year old female patient. The patient's pertinent medical history, concomitant medications and drug allergies or reactions were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient was vaccinated while she was a child. On an unknown date, the patient was diagnosed with shingles (herpes zoster). The patient sought medical attention for the event. The outcome of the event of herpes zoster was unknown. Causality assessment was not provided. There was no product quality complaint associated with the case.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PROQUAD on 1/25/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S013715 and expiration date for 01-NOV-2020 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The temperature and the time frame was unknown by reporter. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with sterile diluent, which was properly stored, lot # S026378 and expiration date 15-MAY-2022.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; 1 patient was administered a dose of Improperly stroed recombivax; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On 19-NOV-2019, the patient administered a dose of improperly stored (product storage error) hepatitis b vaccine thimerosal free (recombinant) (RECOMBIVAX HB) injection, lot # R031052 and expiry date 03-JUN-2021 reported for prophylaxis (strength, dose, frequency, route, anatomical location not reported). No adverse symptoms were reported. Doses of suspect vaccines experienced the temperature excursion below 36 degree Fahrenheit (F) (31.8 F) for 15 minutes. It was reported that there was no previous temperature excursion done. Data logger was involved. No product quality complaint was involved in this report.  This is one of the 3 reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PROQUAD on 25-NOV-2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.  On 25-NOV-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type: rHA, lot # S013715, expiration date: 01-NOV-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis (product storage error). The sterile diluent used to reconstitute was properly stored. Multiple temperature excursions were involved. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint was involved.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 12 month old patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse, referring to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medication was not provided. On 26-NOV-2019, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, schedule, anatomical location and route of administration was not reported) (lot# R034340 and expiry date: 23-NOV-2019) for prophylaxis (expired product administered). There was no associated product quality complaint. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored dose of ROTATEQ; This spontaneous report was received from a health professional (medial assistant) refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 26-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, anatomical location and route were not reported) of lot # R026391 with an expiry date of 09-JUL-2020 for prophylaxis (product storage error). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of lowest temperature below 36 Degree Fahrenheit (9.3 degree F) for a time frame of 1 hour and 30 minutes, exact temperature and time below 24 degree Fahrenheit (9.3 degree F) for 10 minutes, number of cycles below 24 degree Fahrenheit, reported to had 3 cycles. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: developed swelling in the unspecified arm where she was administered the dose; This spontaneous report was received from a physician via company representative referring to a female patient of unknown age (reported as over the age of 65). Information about patient's concurrent condition, medical history, concomitant medication, drug allergy/reaction was not reported.   On 25-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose number, route, anatomical location, lot/batch #, expiration date was not reported) for prophylaxis (reported as vaccination).  On 25-NOV-2019, the patient experienced swelling in the unspecified arm where the dose of vaccine was administered, from her shoulder to elbow(peripheral swelling). No product quality complaint was involved. The outcome of peripheral swelling was unknown. Reporter's causality assessment was not reported.