chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; 12 doses of PNEUMOVAX 23 were administered to 12 different patient's instead of Prevnar 13; She reports out of those 12 patients, 6 were under the age of 2; This spontaneous report was received from a physician referring to 11 patients, 5 were under the age of 2 years old, (one youngest patient was 6 months old was captured in case# 2107USA007992). Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in June 2021, these patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T021485, expiration date 15-MAR-2022, strength and route were not provided) for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered and product administered to patient of inappropriate age). No additional adverse event reported.  This is one of two reports received from the same reporter. This is a non-valid case due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA007992:
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; 12 doses of PNEUMOVAX 23 were administea dose of PNEUMOVAX 23 was inadvertently administered to the patient instead of Prevnar 13red to 12 different patient's instead of Prevnar 13; a dose of PNEUMOVAX 23 was inadvertently administered to the patient instead of Prevnar 13; This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in June 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T021485, expiration date 15-MAR-2022, strength and route were not provided) for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered and product administered to patient of inappropriate age). No additional adverse event was reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA007986:
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Pneumococcal vaccine uptake in pregnant individuals; Information has been received from the authors in a published literature article, entitled as stated below, referring to a retrospective cohort study on pregnant woman, to evaluate the pre and post-guideline cohorts to determine if Tdap vaccine uptake and timing improved after the new Tdap guidelines. Additionally the cohort examined influenza and pneumococcal vaccine uptake before and after guidelines.  The authors found that nearly one-third (N = 675, 29.5%) of individuals were eligible for the pneumococcal vaccine.  No information was provided regarding the patients' medical history, concurrent conditions, past drug history or concomitant medications. Frequency of receiving the pneumococcal vaccine during pregnancy was low throughout the study period, with only 3.8% (N = 8) of eligible individuals in the pre-guideline cohort and 7.3% (N = 32) of eligible individuals in the post-guideline cohort receiving the pneumococcal vaccine (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).  Also the authors observed that there was no significant difference in uptake of the pneumococcal vaccine during pregnancy among eligible individuals in the post-guideline cohort compared to the pre-guideline cohort.  The authors stated that among their study cohort, pneumococcal vaccine uptake was low throughout the study period, consistent with prior reports of poor obstetric provider knowledge about the pneumococcal vaccine. The also stated that a 2020 survey assessing resident knowledge on pneumococcal vaccine during pregnancy found that obstetrics and gynecology residents expressed a comfort level of 3.8/10 in regards to understanding potential candidates for the vaccine.  Another study on a nationally representative sample of residents found that the majority of residents demonstrated low or moderate knowledge of the indications for pneumococcal vaccine during pregnancy.   The authors pointed out that areas for future work include examining whether improving provider knowledge of pneumococcal vaccine eligibility criteria results in improved patient receipt of indicated vaccines  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report: Association of Tdap vaccine guidelines with vaccine uptake during pregnancy.  2021-07-01. 16: 1-12.
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for GARDASIL 9. The vaccine was gien four times today.; no additional adverse effect reported; This spontaneous report was received from a medical assistant and concerns an approximately 18-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (lot # 1687291; expiration date (exp) 11-SEP-2022) (route of administration was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 80.6 Fahrenheit degrees (F) for 14 hours and 51 minutes. There were previous temperature excursions for 73.2 F for 9 hours and 25 minutes; 73.4 F for 8 hours and 48 minutes. The event was reported due to digital data logger. No further information was provided and no additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008709:
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccines administered; This spontaneous report was received from an administrator, referring to a neonate male patient (reported as baby boy). The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot# T022566, expiration date 03-NOV-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -1.4 Centigrade degrees (°C); -26.4°C, for 1 hour; 4 hours. A previous temperature excursion was not reported. A digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA001905: US-009507513-2108USA001815: US-009507513-2108USA001990:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered 10-AUG-2021.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 10-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (strength, dose, formulation, vaccination scheme, route and anatomical location of administration were not reported, lot number T003714, has been verified to be valid, expiration date reported and established as 29-JUL-2021) for prophylaxis (expired product administered). No previous temperature excursion and no additional adverse event were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; administration of improperly stored PROQUAD; This spontaneous report was received from a physician, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml) (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number U006314 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported and upon internal validation established as 24-AUG-2022) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 45.3 degrees Fahrenheit (F) for 17 hours. There was no previous temperature excursion reported. It was unknown if a digital data logger was involved. No adverse events were reported.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse events reported; Caller reports that PNEUMOV AX 23 was given to a 2 month old in error/ Caller reports that PREVNAR 13 was intended to be given to the patient and that this error occurred due to miscommunication; This spontaneous report was received from a medical assistant, referring to a 2-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 11-AUG-2021, the patient was vaccinated in error with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number T020639 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) prefilled syringe, expiration date reported and upon internal validation established as 13-MAR-2022) as prophylaxis, however, the reporter stated that pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was intended to be given to the patient and that this error occurred due to miscommunication (wrong product administered). Additionally, the reporter was inquiring about the contraindications to the use of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in this population. 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 Sharp & Dohme Corp. devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; administration of improperly stored PROQUAD; This spontaneous report was received from a physician who refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # U006314, expiration date: 24-AUG-2022) (strength, route of administration and exact dose were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 45.3 degrees Fahrenheit for a time frame of 17 hours on an unspecified date, without any previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Vaccine excursion occurred on 06-AUG-2021 and was administered on 07-AUG-2021.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided.  On 06-AUG-2021, a temperature excursion was called for a varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, at a temperature of 8.0 degrees Fahrenheit for a time frame of 45 minutes.  On 07-AUG-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) (dose reported as "1 time dose") (strength, vaccination scheme, route and anatomical location of administration were not provided, with lot number T032319 verified as valid and upon internal review expiration date established as 22-SEP-2022) for prophylaxis.  No previous temperature excursions were reported, no information was provided about the use of a data logger. No additional adverse event was reported.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Myocardial infarction
Clinical narrative: heart attack; Bell's Palsy; other zoster related injuries; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 31-MAR-2017 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers and physicians for the following injuries resulting from zoster vaccine live (ZOSTAVAX): heart attack, Bell's Palsy and other zoster related injuries. The outcome of these events was unknown.  Upon internal review, heart attack and Bell's Palsy were determined to be medically significant.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; shingles; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2015 (61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles, vision loss and other zoster related injuries. The outcome of these events was unknown.  Upon internal review, vision loss was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Apparent life threatening event, Illness
Clinical narrative: life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis.   On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter (link case # 2108USA005903).; Sender's Comments:  US-009507513-2108USA005903:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Infant irritability, Infantile spitting up, Vomiting
Clinical narrative: diarrhea with "some" blood in the stool; the patient was "spitting" up a lot.; vomiting the entire day; the patient is still "fussy"; This spontaneous report was received from a doctor concerning a 4-month-old female patient. Pertinent medical history included prolonged jaundice, persistent direct hyperbilirubinemia and hemangioma. Concomitant therapies included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13V (CRM197) (reported as PCV 13).     On 11-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 DS X 10 TUBES 00006404741; lot # 1707460 has been verified to be valid, expiration date reported as 14-MAR-2022; strength was unknown), 1 time dose, orally for prevention of rotavirus gastroenteritis.      On 11-AUG-2021, about an hour after the patient had some food, she experienced vomiting the entire day. The next day the patient was spitting up a lot. On 14-AUG-2021, the patient had diarrhea with some blood in the stool, and streaks of blood in the stool that continued for 2 days. The patient came in to see the doctor on 16-AUG-2021 (also reported as yesterday), and on exam it was noted no abdomen distention and no signs of intussusception. The doctor confirmed that the patient was still "fussy" (onset date: on unknown date in August 2021). The treatment was not given for the events. The patient was recovering from the events. The doctor was reporting this adverse event for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The reporter considered all events to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  Upon internal review, blood in the stool was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 19-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 21-AUG-20106 the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster related conditions. Subsequently, to patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zoster-related conditions. Then, on an unknown date, the patient was hospitalized due to the event .As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of herpes zoster and zoster related conditions was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 0.17
Sex: U
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Haematemesis, Thrombosis
Clinical narrative: the patient was voiting and the vomit had visible blood clots; This spontaneous report was received from a medical assistant via company representative and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date (on the same day), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(strength, dose, dosing schedule, lot# and expiration date were not provided), orally, with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(VAXELIS) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13)(strength, dose, dosing schedule, lot#, expiration date and route of administration were not provided for both). Vaccines were administered for prophylaxis.  On 17-AUG-2021, the patient was vomiting, and the vomit had visible blood clots. The medical attention was sought. Approximately in August 2021, the patient was admitted to hospital due to event and hospitalized for a one day. The patient received unspecified treatment. The patient had made a full recovery approximately in August 2021 and the physicians did not believe that the vomiting was linked to the vaccines that were administered.   The reporting medical assistant did not provide her causality assessment between the subject therapies and the event.      Upon internal review, the event of haematemesis was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Apparent life threatening event, Illness
Clinical narrative: life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis.   On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter (link case # 2108USA004631).; Sender's Comments:  US-009507513-2108USA004631:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored PROQUAD admnistered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # T021301 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 19-DEC-2021) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 9° Celsius (C) for 80 minutes respectively.  If a digital data logger was involved was not reported; measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; expired dose of MMR II was administered to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 16-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (ml), administered subcutaneously (SQ) as prophylaxis (dose number, vaccine scheme and anatomical site of vaccination were not reported; lot number S006051 has been verified to be valid, expiration date reported and established as 27-FEB-2021) (expired product administered). No additional adverse events (AE) reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a patient was administered with a dose of PEDVAXHIB and ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies was provided.  On an unknown date, a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T024020 has been verified to be valid, lot number reported and validated as 31-MAR-2023) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((lot number T033812 has been verified to be valid, lot number reported and validated as 29-DEC-2021) were improperly stored at a temperature of -2.3 degrees Celsius for 9 hours and 12 minutes. There wasn't a previous temperature excursion.  On 20-AUG-2021, the patient was administered with the improperly stored vaccines at a dose of 0.5 milliliter (ml) for prophylaxis (dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported. No other AE or PQC reported.; Medical assistant called to report a temperature excursion. PROQUAD (lot/exp. U009260 9/19/2022) was administered to one patient after the excursion occurred.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 20-AUG-2020, the patient was vaccinated with one (1) time dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 4.6 degrees Celsius (C) with a time frame of 3 hour and 57 minutes (product storage error). No data logger was reported. No previous temperature excursion was reported. No signs or symptoms were reported. No additional adverse event (AE) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that ROTATEQ was administered to one patient following a temperature excursion.; This spontaneous report has been received from an administrator (also reported on physician's field) (conflicting information) referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 20-AUG-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dose number and vaccination scheme frequency were unknown by the reporter; lot number 1707572 was verified to be a valid lot number with an expiration date reported and established as 11-MAR-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 47.3 degrees Fahrenheit (F) with a time frame of 1 hour and 10 minutes (product storage error). No data logger was reported. It was stated that the vaccine had a previous temperature excursion (no details provided). No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T029103, expiration date 23-FEB-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event). No product quality complaint (PQC) was reported.
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: Hospitalized after MMR vaccine in 1989, unknown cause; This spontaneous report was received from a consumer via Pfizer (reference # 2021417258) and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 1989, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiration date, dose, route, frequency and indication were not reported).  On an unknown date, the patient experienced an unspecified adverse event and, due to that, she was hospitalized on an unreported date.  At the reporting time, the outcome of adverse event was not reported. The reporter did not provide a causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; bumps on his neck; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (shingles) and RASH (bumps on his neck) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis of neck (lower back and neck arthritis). Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles). 26-Feb-2021, the patient experienced RASH (bumps on his neck). On 05-Mar-2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, RASH (bumps on his neck) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   medical history of lower back and neck arthritis was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Treatment drug (Valcyclovir) was prescribed and medical history was reported.
Sex: U
Vaccine: ANTH
Symptoms: Inappropriate schedule of product administration, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Swelling in her arm; Inappropriate schedule of product administration; A spontaneous report was received on 03AUG2021 from another pharmaceutical company.   On 30JUL2021, a 55 year-old female patient reported experiencing swelling in her arm (PT: Injection site swelling) after receiving the "Anthrax shot". The patient received BioThrax (anthrax vaccine) 0.5cc on 03MAY2004, 17MAY2004 and 01JUN2004 (Inappropriate schedule of product administration). After each dose, she developed swelling in her arm. She described that after receiving the first dose she had swelling slightly, after receiving the second dose, she had a little more swelling, and after the third dose she had really bad swelling in her right arm and it was a lot. Expiry date and Lot Number were unknown. The patient attributes the swelling in her arm as related to the anthrax vaccine. The outcome of the events were resolved.  Medical history includes Methicillin-resistant Staphylococcus aureus (MRSA) infection in 2012. Concomitant medications were not reported.  No further information is available.  Company comment:  Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.; Sender's Comments: Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got my 2 vaccine back in October and I have shingls/ suspected Vaccination failure; I have shingls; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Cream (Nos)) and antibiotics nos. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2 vaccine and had shingles now at the time of reporting, but luckily very little and no pain, treated with cream and antibiotic and that was it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 shots still got them /suspected Vaccination failure; Had 2 shots still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, had 2 shots still get shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Get that shot. I had them/ suspected vaccination failure; I had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got that shot and had them. The patient was going to ask about another shot for himself or herself. The patient stated that for years after patient got them and would feel pain deep down in that area, but forget that he or she was not into pain. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175994:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Herpes zoster oticus, Incomplete course of vaccination
Clinical narrative: Face paralysis; Ramsay Hunt Disease; got single dose years ago; This case was reported by a consumer via  media and described the occurrence of facial paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and ramsay-hunt syndrome were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the facial paralysis and ramsay-hunt syndrome to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced Ramsay-Hunt disease. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176023, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176023:Dad's wife case
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Myarm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th August 2021, the patient received Shingles vaccine. On 18th August 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that got the shingles vaccine and arm hurt from that shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This case was reported by a consumer via media and described the occurrence of heart attack in a 51-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the heart attack was unknown.   It was unknown if the reporter considered the heart attack to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle shot and had heart attack, which was more difficult to recover. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Facial paralysis, Incomplete course of vaccination
Clinical narrative: Face paralysis; Bells palsy; Incomplete course of vaccination; This case was reported by a consumer via media and described the occurrence of facial paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and bell's palsy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the facial paralysis and bell's palsy to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced bell's palsy. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176003, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176003:Dad's case
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Illness, Pyrexia
Clinical narrative: sick; slight fever; left arm got real red; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on the inside of the body all 3 times its even worse).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and erythema of extremities. On an unknown date, the outcome of the sickness, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she did get the 2 Shingrix shots for shingles this was in 2019, it was the best thing the patient did for himself/herself and yes it made him/her sick with a slight fever and his/her left arm got real red but after 2 days the patient was fine and have been ever since, the patient pay dollar 300, for both out of pocket, patient said he/she on but had to do it, hope who ever gets the shots would get better. The patient also had both Covid shots (Pfizer), was only sick for 2 days with fever this was 6 months ago from the time of reporting. The patient was doing fine, he/she did this for himself/herself and the patient just went to get his/her Flu shot last week, from the time of reporting that one patient get every year. For the tolerance of the 2nd dose, refer case US2021AMR178357 , reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178357:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; My dad still got them and does not prevent them from happening; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient received shingles vaccine but still experienced shingles.  The reporter stated that the vaccine did not prevent shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case had been linked with the case US2021AMR176054 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176054:Same reporter