chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, SARS-CoV-2 test
Clinical narrative: Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female consumer (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) in left arm, on 01Apr2021 at 10 AM, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma and migraines. The patient did not have COVID prior to vaccination. Known allergies: No. Other medications in two weeks: medications for pain in knees were injected. On an unspecified date the patient experienced facial paralysis. The event required treatment (physical therapy) and had not yet resolved at the time of report. COVID was tested post vaccination, on 05Mar2021: nasal swab sample/molecular was negative.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain/impingement starting more than a week after the vaccination. it has lasted to now.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Chest discomfort, Pharyngeal swelling, Swelling face
Clinical narrative: Facial and throat swelling, angioedema of lip, chest toghtening
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling, Sensation of foreign body
Clinical narrative: Facial and throat swelling, angioedema of lip, chest toghtening
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 3 days after vaccine dose number one. I woke up with hives covering my upper legs, partially lower legs, partial back, partial upper arms, entire side mid section and partial waste line. Antihistamine and cortizone ointment started immediately. Showing slight improvement from initial reaction time.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Started feeling swelling/pain in left armpit region late on the night of the 29th. Woke up and still had that pain. On the evening of the 30th (around 9 PM) noticed that the lymph node above the left clavicle had swollen up to about the size of a marble and was causing pain, both when not being touched and when being touched.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: Low grade fever - 10 hours after vaccine skin sensitivity (not aches) - 10 hours after vaccine   both of these were present in first dose but not until 22 hours after vaccination
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Moderate Itchiness all over the body. The onset of the itchiness was within 1 hour of the vaccine. The itchiness has persisted every day since then. The itchiness is most itchy in the groin/scrotrum region and inner thighs. Other parts of the scrotum/groin are also itchy every day ever since getting the vaccine. The individual has no STDs and had only normal male itching prior to the vaccine.   There is also itching on the arms, lower neck/sides of neck, thighs, and sides of the back, but not as intense itching as the areas described above. I had never experienced generalized itching on my body ever before getting the JNJ vaccine and am positive it is related.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Swelling in the injection site (it?s red, itches and it?s the size of a tennis ball), chills,  headache, back ache, neck pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Neck pain
Clinical narrative: Swelling in the injection site (it?s red, itches and it?s the size of a tennis ball), chills,  headache, back ache, neck pain.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hot flush, Neck pain, Pain
Clinical narrative: Severe headache, hot flashes, neck and body pain
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: After vaccine no period. Very high temperature 39.5 C first day and 38-38.5 C at second day.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Feeling hot, Pain
Clinical narrative: Flu-like aches and extreme weakness throughout the body starting 7-8 hours after injection. Went to sleep the night of the injection feeling the onset of these side effects, which intensified throughout the night and disturbed quality of sleep.  Weakness and pain kept me in bed for the entire next day, with shooting pains up my skull behind my ears. Was unable to even sit up for more than a few minutes without pain and fatigue making me lie prone again. No fever, but felt hot throughout body. No chills - or maybe very mild chills.   Treatment: took a capsule of skullcap in the middle of the day, which seemed to alleviate my discomfort enough to let me nap.   Flu-like side-effects ceased abruptly around 10pm on 4/29 the day after injection, lasting about 24 hours total.  The following day, 4/30 around 7pm (so ~48 hours after injection), I developed COVID arm during moderate physical exercise. Suddenly felt and saw a hot, red, swollen rash on my upper left arm under - not around - the injection site (I am right - hand dominant). Rash is visibly swollen, mainly itchy, and tender/painful to touch if I press  on it.  Rash persists 8 hours later as of this writing. No treatment attempted for rash.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash papular, Rash pruritic, Skin warm
Clinical narrative: Flu-like aches and extreme weakness throughout the body starting 7-8 hours after injection. Went to sleep the night of the injection feeling the onset of these side effects, which intensified throughout the night and disturbed quality of sleep.  Weakness and pain kept me in bed for the entire next day, with shooting pains up my skull behind my ears. Was unable to even sit up for more than a few minutes without pain and fatigue making me lie prone again. No fever, but felt hot throughout body. No chills - or maybe very mild chills.   Treatment: took a capsule of skullcap in the middle of the day, which seemed to alleviate my discomfort enough to let me nap.   Flu-like side-effects ceased abruptly around 10pm on 4/29 the day after injection, lasting about 24 hours total.  The following day, 4/30 around 7pm (so ~48 hours after injection), I developed COVID arm during moderate physical exercise. Suddenly felt and saw a hot, red, swollen rash on my upper left arm under - not around - the injection site (I am right - hand dominant). Rash is visibly swollen, mainly itchy, and tender/painful to touch if I press  on it.  Rash persists 8 hours later as of this writing. No treatment attempted for rash.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Flu-like aches and extreme weakness throughout the body starting 7-8 hours after injection. Went to sleep the night of the injection feeling the onset of these side effects, which intensified throughout the night and disturbed quality of sleep.  Weakness and pain kept me in bed for the entire next day, with shooting pains up my skull behind my ears. Was unable to even sit up for more than a few minutes without pain and fatigue making me lie prone again. No fever, but felt hot throughout body. No chills - or maybe very mild chills.   Treatment: took a capsule of skullcap in the middle of the day, which seemed to alleviate my discomfort enough to let me nap.   Flu-like side-effects ceased abruptly around 10pm on 4/29 the day after injection, lasting about 24 hours total.  The following day, 4/30 around 7pm (so ~48 hours after injection), I developed COVID arm during moderate physical exercise. Suddenly felt and saw a hot, red, swollen rash on my upper left arm under - not around - the injection site (I am right - hand dominant). Rash is visibly swollen, mainly itchy, and tender/painful to touch if I press  on it.  Rash persists 8 hours later as of this writing. No treatment attempted for rash.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder
Clinical narrative: I am breastfeeding. I am experiencing significantly leas breast milk production after second covid shot.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: the patient did not experience untoward effects after receiving the vaccines, and required no medical interventions.; MMRII was administered post excursion; This spontaneous report has been received from a Medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 08-FEB-2021, the patients were vaccinated with the following improperly stored vaccines for prophylaxis:  - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). - haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) - hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  The dosage regimen, anatomical location, Lot # and expiration dates were not reported.  It was reported that the temperature excursion took place as follows:  For measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) temperature excursion was in between -58°Fahrenheit (F) -+ 46°F, specifically at 39.9°F for 7 hours and 44 minutes.   For haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the temperature excursion was in between 36 °Fahrenheit (F) to 46°F, specifically at 39.9°F for 7 hours and 44 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  This is a non valid case due to lack of patients' identifiers.   Follow up information has been recieved from the medical assistant on 23-APR-2021.  Patient identifiers were provided, the case concerns a 12-month-old female patient.   Concomitant vaccinations included varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis A virus vaccine (unspecified). The patient was also taking multivitamins.  On 03-FEB-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneous route in her right arm, lot number S037503 (rHA), expiration date 20-NOV-2021.   The reporter confirmed that the varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis A virus vaccine (unspecified) had not undergone a temperature excursion and were administered according to the prescribing information.   It was also reported that the patient did not experience untoward effects after receiving the vaccines, and required no medical interventions.   The reporter stated that no patient ever received the haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) or the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that were reported initially. She added that the vaccines had been kept in "normal temperatures" and denied they had undergone a temperature excursion.   It was confirmed that only one patient received the vaccine that had undergone a temperature excursion.
Age: 34.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: administration of Varivax to her daughter-in-law that is 12 weeks pregnant; soreness in right arm due to administration of vaccine; This spontaneous prospective pregnancy report was received from a patient's mother-in-law and refers to a 34-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported. The patient's medical history included chickenpox. She became pregnant with last menstrual period (LMP) of 06-JAN-2021 and estimated due date (EDD) of 12-OCT-2021.  On 25-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) in the right deltoid, for prophylaxis (lot # T028304 was verified to be valid, expiration date reported and established as 20-AUG-2022), (dose and route of administration were not provided). On the same day, the patient was also vaccinated with an unspecified influenza virus vaccine (reported as flu vaccine) in the right deltoid (strength, dose, frequency, route of administration, indication, lot number and expiration date were not provided).  Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) and the flu vaccine was at 11 weeks. The pregnancy outcome was pending. The reporter stated that the patient checked the box indicating that she was pregnant on her paperwork. The patient's provider was notified and informed of the administration of varicella virus vaccine live (oka/merck) (VARIVAX). The patient was informed that her pregnancy would be continually monitored. On an unknown date in March 2021, the patient experienced also soreness in her right arm. The patient did not seek medical attention and there was no treatment given for the event. The outcome of the event was unknown.  The reporter considered vaccination site pain to be related to the suspect vaccines (reported as "due to administration of vaccines").
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 3 doses of PROQU AD were administered to patients at unknown times following a temperature excursion; No additional adverse events or any product quality complaints were reported; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength was not reported; dose: 0.5 ml, injected, once, lot # was T023918, expiration date was reported as 09-JAN-2022) for prophylaxis following a temperature excursion (product storage error). The previous temperature excursion was 18 Fahrenheit (F) for 1 hour 30 minutes. Temperature was 5.68 F with a time frame of 5 minutes. Digital data logger was involved. No additional adverse events or any product quality complaints were reported in this case.  This is one of 2 reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any other AEs; received an expired dose of PEDVAXHIB; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 02-APR-2021, the patient received an expired dose of haemophilus b conjugate vcaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # s030207 which was an invalid lot number, expiration date was reported as 25-MAR-2021, strength and route were not reported) for prophylaxis (expired vaccine used). The vaccine did not have any temperature excursions prior to administration. The patient did not experience any other adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addditional adverse effect reported; Incorrect product storage; This spontaneous report was received from an unspecified reporter, and refers to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 02-MAR-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024369, expiration date: 06-AUG-2021, for prophylaxis.         On an unspecified date, before admninistration, the dose of varicella virus vaccine live (oka/merck)(VARIVAX) underwent temperature excursions of 14 Fahrenheit degrees (°F) to 46 °F for 2 hours. There were no previous temperature excursions.  Call was made by the data logger.   After administration no adverse effects were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; VARIVAX was inadvertently administered after expiration; This spontaneous report as received from a nurse practitioner referring to a male patient of unknown age and race.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  The nurse stated that on 06-APR-2021 (reported as today), the patient was inadvertently administered with varicella virus vaccine live (oka/merck) (VARIVAX) after expiration date, 1 time dose (lot # S010296, expiration date 03-APR-2021, exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse events were reported. It was provided that the vaccine was purchased with private funds and facility type was provided as public health clinic/ hospital. An agent had confirmed that no temperature excursions have occurred. Digital Data Logger was not involved. The vaccine was not available for return/evaluation because that was the last one.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: no additional adverse event reported; The vaccine was reconstituted with normal saline sodium chloride (manufacturer unknown) rather than the Merck diluent and administered to the patient; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 09-APR-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dosage, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with normal saline sodium chloride (manufacturer unknown) rather than the Merck diluent and administered to the patient.   No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller stated the vaccine was improperly stored and administered to a patient; The product was placed in the refrigerator with MMRll and given to a patient that was to receive MMRll; This spontaneous report as received from a registered nurse refers to a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 14-APR-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S035107 expiration date 03-MAY-2021, 0.5 milliliter for prophylaxis, but he was to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Caller stated it was unknown how long the vaccine was stored in the refrigerator.       Digital Data Logger registered a temperature excursion of 40 Fahrennheit degrees up to 2376 hours.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient had received the vaccine for MMR and Varicella in the past/Proquad was not needed; Information has been received from a Registered nurse concerning to a 12 years old female patient. On 16-MAR-2021, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S030211, exp. date 25-MAR-2021) (rHA), 0.5 milliliter for prophylaxis, as the clinic did not have her vaccine records. On an unknown date, the clinic discovered that in the past the patient was vaccinated with measles (+) mumps (+) rubella (manufacturer unknown) and varicella (manufacturer unknown), therefore measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not needed (extra dose administered).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA003950:
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; accidentally gave PNEUMOVAX 23 to a 6 month old instead of the PREVNAR 13; This spontaneous report as received from a physician refers to a 6-month-old female patient.  On 15-APR-2021, the physician accidentally gave pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, LOT#, expiration date, route of administration and injection site were not provided) for prophylaxis to the patient instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; During vaccine administration the patient pulled the syringe out resulting in incomplete dose.; During vaccine administration the patient pulled the syringe out resulting in incomplete dose.; This spontaneous report was received from a licensed practical nurse concerning a 1-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were reported as no.   On 20-APR-2021, the patient was vaccinated with a partial dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (dosage regimen and anatomic site were not provided) (lot number T005737 and expiration date 10-JUN-2022 were verified as valid) as routine vaccination for Haemophilus influenzae type b. The reporter stated that the patient pulled the syringe out resulting in incomplete dose (underdose) (incorrect dose administered). . However, it was reported that the patient recovered on the same date (discrepant information). No additional adverse event was reported. It was also reported that no treatment was given, no diagnostic laboratories or studies were performed, neither medical attention was sought because the event occurred while in a clinical setting.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose of MMR-II was administered to a consumer; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's current condition, historical condition and concomitant medications were not reported.  On 20-APR-2021, the patient was vaccinated with an expired dose (expiration date: 17-DEC-2020) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, anatomical location and lot number were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: She wanted to know if the dose needed to be repeated; No additional AE reported; PROQUAD dose had been administered intramuscularly instead of subcutaneously; This spontaneous report was received from a physician refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 21-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter, lot# reported as "T033664", expired dose of 31-MAR-2022 had been administered intramuscularly instead of subcutaneously. She wanted to know if the dose needed to be repeated. No adverse event has been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 08-MAY-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for prevention of shingles. After receiving the vaccine, the pt suffered from an outbreak of shingles (herpes zoster). As a result of the event, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered as a disabling event by the reporter.
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event reported; 7 month old inadvertently received the PNEUMOV AX 23 PFS instead of the PREVNAR 13 vaccine; This spontaneous report was received from the medical assistant and refers to a 7-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-APR-2021, the patient was inadvertently vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot # T033369, expiration date 26-MAY-2020 (exact dose, route of administration and anatomical location were not reported) instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (wrong vaccine administered). Vaccine was administered for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T033369; expirationdate: 26-MAY-2022; 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
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported; improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a 12-year-old female patient. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 21-JAN-2021, the patients were vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # 1621929, expiration date 23-APR-2021 intramuscularly in left arm; conflicting information, previous dose was 3) for prophylaxis (product storage error). The administered dose was exposed to the temperature of 10.13 degrees Celsius (C) for 1 hour. There were previous temperature excursions reported as 9.17 C for 15 minutes and 8.59 C for 15 minutes. The call was because of a digital data logger. The patient did not experience an adverse reaction.  This is one of several reports received from the same reporter. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: 1621929; expiration date: 23-APR-2021; device age and unit: 0 ; operator of device: Health Care Professional; malfunction: Unknown; device usage: Initial; reason for non eval: 81 Other; follow up additional info :Yes; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA006855:
Sex: M
Vaccine: VARZOS
Symptoms: Blindness transient, Deafness, Deafness neurosensory, Ear pain, Fatigue
Clinical narrative: Sensorineural hearing loss; Herpes Zoster Oticus/bilateral ear pain; Meniere's disease; Bilateral Transient Visual Loss/bilateral blurry vision; neuropathic pain/constant headache and fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 14-NOV-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced hearing loss and bilateral ear pain therefore was diagnosed with sensorineural hearing loss (deafness neurosensory), herpes zoster oticus and Meniere's disease. The pt. also claimed suffered bilateral blurry vision, constant headache and fatigue which were diagnosed as bilateral visual loss (blindness transient) and neuropathic pain (neuralgia). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in 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 pt. sustained severe and permanent personal injuries. The pt. 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; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered deafness neurosensory, herpes zoster oticus, Meniere's disease, blindness transient and neuralgia to be disabling events.  Upon internal review, the events deafness neurosensory, herpes zoster oticus, Meniere's disease, and blindness transient were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster oticus, Meniere's disease, Neuralgia, Vision blurred
Clinical narrative: Sensorineural hearing loss; Herpes Zoster Oticus/bilateral ear pain; Meniere's disease; Bilateral Transient Visual Loss/bilateral blurry vision; neuropathic pain/constant headache and fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 14-NOV-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced hearing loss and bilateral ear pain therefore was diagnosed with sensorineural hearing loss (deafness neurosensory), herpes zoster oticus and Meniere's disease. The pt. also claimed suffered bilateral blurry vision, constant headache and fatigue which were diagnosed as bilateral visual loss (blindness transient) and neuropathic pain (neuralgia). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in 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 pt. sustained severe and permanent personal injuries. The pt. 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; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered deafness neurosensory, herpes zoster oticus, Meniere's disease, blindness transient and neuralgia to be disabling events.  Upon internal review, the events deafness neurosensory, herpes zoster oticus, Meniere's disease, and blindness transient were considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Cough, Inappropriate schedule of product administration
Clinical narrative: Pneumonia vaccine every 2 years; This spontaneous report was received from a consumer via Pfizer and refers to a male patient of unknown age. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD) and type II diabetes and his historical conditions included pneumonia 5 times that required hospitalization 4 times. The patients historical vaccines included shingle shot (manufacturer unknown).  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) every 2 years.  The patient subsequently experienced missed dose, product prescribing issue and dry cough while on therapy with lisinopril (manufacturer unknown) and tozinameran (COMIRNATY) (case # 2104USA006761).; Sender's Comments:  US-009507513-2104USA006761:
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; Patient was inadvertently administered GARDASIL 9 instead of the intended PEDVAX HIB; This spontaneous report was received from a medical assistant and refers to 4-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-APR-2021, the patient was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) instead of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). The vaccine was administered for prophylaxis. No additional adverse event was reported.
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered expired GARD ASIL 9 vaccine; This spontaneous report was received from a pharmacist and refers to 30-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-APR-2021, the patient was vaccinated with expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # R017624, expiration date 17-MAR-2021 (exact dose, route of administration and anatomical location were not reported), for prophylaxis. No additional adverse event was reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: adverse reaction: none; date of vaccination : 2018, 2019; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet, from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2101USA011905), refers to an approximately 69 years old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. She was administered unspecified flu vaccine, annually, since as long she could remember till present. On an unknown date in 2015, she received vaccination with zoster vaccine live (ZOSTAVAX).  On an unspecified date in 2018 and subsequently in 2019, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The patient experienced inappropriate schedule of vaccine administration. The patient had none of adverse reaction or side effects experienced.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2101USA011905:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional ae; Temperature excursion of VARIVAX; This spontaneous report was received from an other health professional and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 12-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826 with expiration date 25-JUN-2022 (dose, strength, route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursions of -58 Fahrenheit (F) degrees and +5 F degrees (6.3 F) for 6 hours, 0 minutes and 30 seconds, -58 Fahrenheit (F) degrees and +5 F degrees (10.9 F) for 0 hours, 7 minutes and 30 seconds. Digital data logger was involved. There was previous temperature excursions. No additional adverse events reported.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Cerebrovascular accident, Dysarthria, Fatigue, Gait inability
Clinical narrative: Cerebral Vascular Accident; Shingles; Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. On or about 26-JUN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered inability to walk, weakness in left side, fatigue, no control of left side and slurred speech and he was diagnosed with a cerebral vascular accident; patient suffered pain in the back and noted visible lesions scabbing and sensitivity to touch and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident and herpes zoster was unknown. The reporter considered cerebrovascular accident and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of cerebrovascular accident  was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Hemiparesis, Herpes zoster, Scab, Skin lesion, Skin sensitisation
Clinical narrative: Cerebral Vascular Accident; Shingles; Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. On or about 26-JUN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered inability to walk, weakness in left side, fatigue, no control of left side and slurred speech and he was diagnosed with a cerebral vascular accident; patient suffered pain in the back and noted visible lesions scabbing and sensitivity to touch and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident and herpes zoster was unknown. The reporter considered cerebrovascular accident and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of cerebrovascular accident  was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse eents reported; she gave a dose of PROQUAD today that expired on 07-APR-2021; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 27-APR-2021, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031884 with expiration date 07-APR-2021(dose, strength, route of administration were not provided) for prophylaxis. The vaccine was properly stored up through the time of vaccination. No additional adverse events reported.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; improperly stored temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On 22-APR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date was provided and also validated as 25-JUN-2022 (dose, strength, route of administration and anatomical location were not reported) for prophylaxis (improper storage of product in use). On 22-APR-2021, the data logger detected, that the involved vaccine was stored at the temperature of 6.3 degree Fahrenheit (F) for 6 hours and 30 seconds, at the temperature of 10.9 F for 7 minutes and 30 seconds, at the temperature of 6.3 F for 6 hours and 30 seconds, and at the temperature of 10.9 F for 7 minutes and 30 seconds. The data logger detected temperature excursion previously. No additional adverse event (AE) was reported (no adverse event).  This is one of the 5 linked reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008255: US-009507513-2104USA008185: US-009507513-2104USA008081: US-009507513-2104USA008022:
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Ophthalmic vein thrombosis
Clinical narrative: Blood clot in the right eye; This is a spontaneous report from a contactable consumer(patient) based on information received by Pfizer, license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC VEIN THROMBOSIS (Blood clot in the right eye) in male patient of an unknown age who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started Eliquis (unknown route). On 07-Jan-2021, the patient started Covid-19 Vaccine (unknown route). In April 2021, the patient experienced OPHTHALMIC VEIN THROMBOSIS (seriousness criterion medically significant). The action taken with Eliquis (Unknown) was unknown. At the time of the report, OPHTHALMIC VEIN THROMBOSIS outcome was unknown. The consumer received his first Pfizer covid 19 shot on 07-Jan-2021 and the second one on 28-Jan- 2021, and 10 days prior to this report he got a blood clot in his right eye. He takes a blood thinner and remarks this should keep him from getting blood clots, should not it. Blood thinner provided was Eliquis. The event was related to covid 19 vaccine and causality with Eliquis was not provided. For Eliquis (Unknown), the reporter did not provide any causality assessments. This case was received via pfizer.  BMS Medical Evaluation Comment: This patient had ophthalmic vein thrombosis while on therapy with apixaban and after taking covid 19 vaccine. Underlying thromboembolic risk as ascertained by the use of apixaban is a significant factor that likely predisposed the patient to develop ophthalmic vein thrombosis and considered not related to apixaban therapy.  Causality Assessment: For apixaban: the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was not provided Per Reporter; the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was Not Related Per Company (Bristol-Myers Squibb)