chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: a patient in their office today was given an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-AUG-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot # R030929, expiration date 23-JUL-2020 (dose number, vaccination site and route of administration were not provided) for prophylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: on unspecified dates, unspecified patients were administered improperly stored ROTA TEQ and PEDVAX HIB.; 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 and medical history were not reported.      On unknown dates, an unspecified number of patients  were vaccinated with the following improperly stored vaccines:  - Rotavirus vaccine, live, oral, pentavalent(ROTATEQ) for prophylaxis,  Lot # 1684152, expiration date reported as 16-JUN-2021 (dosage regimen was not reported).   - Haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscular injection, Lot# S000355,  expiration date 10-OCT-2021 for prophylaxis (dosage regimen was not reported).    The storage temperature for both vaccines was reported to have been at 26° Fahrenheit (F) for a time frame of 62 hours.  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.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; a patient was administered an improperly stored PNEUMOVAX 23; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S029542, expiration date 10-JUN-2021; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature and time frame were reported as above 47 degrees Fahrenheit (70 degrees Fahrenheit) for 12 hours. There was no previous temperature excursion. Data logger was not involved. There was no additional adverse events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia.; shingles; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On unknown date, in 2014 patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for shingles and post herpetic neuralgia. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical 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. At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, regarding a male patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On unknown date, in 2014 patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions, at the pharmacy. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical 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. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: the patient was treated by a healthcare provider for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.   The patient's current conditions, medical history and concomitant medications were not reported.   In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route, dosage information and lot number were unknown) for long-term prevention of shingles and/or zoster-related conditions.  On an unknown date the patient experienced herpes zoster and was hospitalized.       It was also mentioned that as a direct and proximate result of Patient's use of the zoster vaccine live (ZOSTAVAX), the Patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was reported as not recovered.  The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The patient was administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-MAR-2020, the patient received improperly stored vaccine doses. At 10:21, the patient received an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219 (expiration date 03-MAR-2022), 0.5 mL intramuscularly (IM) on the left thigh (LT) and at 11:22, an improperly stored dose of Hepatitis A Vaccine (HEP A) (manufacturer unknown) lot # 747P5 (expiration date not reported), 0.5 mL IM on the LT. Both vaccines were administered for prophylaxis.   It was reported that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) was stored above 9 Celsius degrees (at 15.5 Celsius degrees) for 4 hours and 6 minutes and a digital data logger was involved; for Hepatitis A Vaccine (HEP A) (manufacturer unknown), no information was provided. No adverse effects were reported.  This was one of several cases received from the same reporter.  Lot number 747P5 is an invalid lot number for Hepatitis A Vaccine, Inactivated.; Sender's Comments:  US-009507513-2003USA002275: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2008USA008876: US-009507513-2008USA008883: US-009507513-2008USA008875: US-009507513-2008USA008880: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008878: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to an unspecified  patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 25-MAR-2020, the patient was vaccinated with improperly stored doses of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S030206 with expiration date of 25-MAR-2021(upon internal validation),0 .5 milliliter, subcutaneous in the left thigh for prophylaxis and diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(KINRIX). No adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008883:Original Case : 2003USA002275 US-009507513-2008USA008876:Original Case : 2003USA002275 US-009507513-2008USA008875:Original Case : 2003USA002275 US-009507513-2008USA008877:Original Case : 2003USA002275 US-009507513-2008USA008878:Original Case : 2003USA002275 US-009507513-2008USA008879:Original Case : 2003USA002275 US-009507513-2008USA008880:Original Case : 2003USA002275 US-009507513-2008USA008881:Original Case : 2003USA002275 US-009507513-2008USA008884:Original Case : 2003USA002275 US-009507513-2008USA008886:Original Case : 2003USA002275 US-009507513-2008USA008887:Original Case : 2003USA002275 US-009507513-2008USA008889:Original Case : 2003USA002275 US-009507513-2008USA008889:Original Case : 2003USA002275 US-009507513-2008USA008890:Original Case : 2003USA002275 US-009507513-2008USA008891:Original Case : 2003USA002275 US-009507513-2008USA008892:Original Case : 2003USA002275 US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-MAR-2020 at 14:30 hours, the patient was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with a lot # reported as 1621931 (Reporter reported Gardasil with lot # 1621931 which was not valid for Gardasil . However, lot# 1621931 is valid for Gardasil 9) at a dose of 0.5 mL intramuscularly (IM) on the left arm (LA)for prophylaxis, however no adverse effects reported.   Administered dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008876: US-009507513-2008USA008911: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008881: US-009507513-2008USA008880: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008904: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008898: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008901: US-009507513-2008USA008932: US-009507513-2008USA008903: US-009507513-2008USA008909: US-009507513-2008USA008907: US-009507513-2008USA008906: US-009507513-2008USA008920: US-009507513-2008USA008882:
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 14-months-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 28-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021), with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) intramuscular (IM) (lot number 1595K with an expiration date on 30-DEC-2021); with the third dose diphtheria toxoid, Hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) IM (lot number NJ227AAA with expiration date on 23-APR-2021); and with the third dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (for those three vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA001768: US-009507513-2008USA009257: US-009507513-2008USA009258: US-009507513-2008USA009259:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021), and with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX) intramuscular (dose, frequency, indication and anatomical injection site were not reported; lot number PP9L5 with expiration date on 16-OCT-2021).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA009256: US-009507513-2008USA001768: US-009507513-2008USA009258: US-009507513-2008USA009259:
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPIPV, HIBV, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 15-months-old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021); with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX) intramuscular (IM) (lot number 7595K with expiration date on 30-DEC-2021); with the first dose of Hib conj vaccine (tet toxoid) (ACTHIB) IM (lot number NJ165AAA with expiration date on 29-MAY-2021); with the fourth dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) IM (lot number CN0615 with expiration date on April 2022); and with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (INFANRIX) (lot number D2KX9 with expiration date on 26-NOV-2021) (for those four vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA009256: US-009507513-2008USA009257: US-009507513-2008USA001768: US-009507513-2008USA009259:
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021); with the fourth dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) intramuscular (IM) (lot number CN0615 with expiration date on April 2022); with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) (IM) (lot number 7595K with expiration date on 30-DEC-2021); and with the first dose of Hib conj vaccine (tet toxoid) (ACTHIB) IM (lot number NJ165AAA with expiration date on 29-MAY-2021) (for those three vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.  .; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA009256: US-009507513-2008USA009257: US-009507513-2008USA009258: US-009507513-2008USA001768:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired PROQUAD was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not provided; lot number S003862, expiration date: 08-AUG-2020) as prophylaxis (expired product administered). According to the reporter, there were no previous temperature excursions.
Age: 42.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC identified; vaccine that underwent a temperature excursion was administered to a patient; Information has been received from a nurse referring to a 42 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 06-AUG-2020, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S015961 and expiration date 23-MAY-2021; strength, dose and route were unknown) that underwent a temperature excursion (product storage error). The vaccine was exposed to temperature excursion at above 47 degrees Fahrenheit (49.3 degrees Fahrenheit) for 43 minutes, above 47 degrees Fahrenheit (49.3 degrees Fahrenheit) for 93 minutes and above 47 degrees Fahrenheit (49.6 degrees Fahrenheit) for 30 minutes. The cumulative time was 2 hours and 52 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse events were identified.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: pain was spreading to lower arm; redness was spreading to lower arm; swelling at the injection site; redness at the injection site; pain/tenderness at the injection site; This spontaneous report was received from a pharmacist, concerning a 75 year old female patient.  Information on concurrent conditions, medical history or concomitant medications was not provided.   On 14-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S024808, expiration date:02-JUN-2021) 0.5 milliliter, intramuscular for prophylaxis.  (dose number, and anatomical location were not reported).  On 15-AUG-2020, The patient returned to the pharmacy after the vaccination seeking medical advice with complaints of redness, swelling, pain/tenderness at the injection site. The pharmacist recommended applying ice to the area and over-the-counter (OTC) pain medication (unspecified) for treatment of the reported tenderness in the affected arm (also reported that no treatment was given due to the events, conflicting information). The patient returned to the pharmacy on 17-AUG-2020 (also reported as today), reporting that the swelling had decreased, but she was still experiencing pain, and redness at the site and that it was spreading to lower arm. The patient would be referred to a healthcare professional (CHP) for further assessment. At the moment of this report, the patient was recovering from swelling at the injection site and had not recovered from the events.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effects reported.; then inadvertently received a second dose on 18-AUG-2020.; This spontaneous report was received from a nurse, referring to 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 16-JUL-2020, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported), as prophylaxis.   On 18-AUG-2020, the patient inadvertently received a second dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection (lot number S021457 which has been verified to be valid, expiration date reported and validated as 03-MAR-2022) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (inappropriate schedule of product administration). No additional adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Nausea
Clinical narrative: caller is complaining of nausea; states she is 7 months, 28 weeks, and in her 3rd trimester of pregnancy and was inadvertently administered GARDASIL 9 instead ofRhoGAM; states she is 7 months, 28 weeks, and in her 3rd trimester of pregnancy and was inadvertently administered GARDASIL 9 instead ofRhoGAM; Gardasil 9 for negative blood type; This spontaneous prospective pregnancy report was received from a 27-year-old female patient regarding herself. The patient's concurrent conditions included migraines and allergy to latex. The patient's historical conditions were not reported. Concomitant therapy included unspecified prenatal vitamins, propranolol, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and fish oil.  On 17-AUG-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, in her right arm (dose, lot number and expiration date were not reported) as the patient had negative blood type and was supposed to received Rho(D) immune globulin(RHOGAM).   The patient stated that healthcare professional (HCP) informed her of a similar accident that occurred at another clinic and the HCP checked with the chief medical officer who said everything would be fine. On 18-AUG-2020 (reported as today), the patient went back to her HCP and received the received Rho(D) immune globulin(RHOGAM) in her left hip. The patient was complaining of nausea. Also, the patient stated she has heard there have been studies with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) performed in pregnant mice. The patient also stated there have been no human trials conducted with pregnant women and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient did not seek medical attention and no treatment was given for the event. No diagnostic laboratories were performed.  At the time of the report, the outcome of nausea was unknown.  The relatedness between the event of nausea and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 28-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010137: US-009507513-2008USA010136:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored dose of VARIVAX was administered; no additional adverse effects; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 17-AUG-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S020158 and expiration date 30-JUN-2021, for prophylaxis (dose, strength and frequency).         It was reported that varicella virus vaccine live (oka/merck)(VARIVAX) was stored at a temperature of (15°F to 46°F): 19.2F durinf 1 hour and 46 minutes. No previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 29-JUL-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 30-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 31-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 03-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 04-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 04-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 05-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 05-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010136:Original Case : 2008USA010128 US-009507513-2008USA010137:Original Case : 2008USA010128 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010135:Original Case : 2008USA010128 US-009507513-2008USA010134:Original Case : 2008USA010128 US-009507513-2008USA010121:Original Case : 2008USA010000 2008USA010136: US-009507513-2008USA010137: US-009507513-2008USA010136: US-009507513-2008USA010134: US-009507513-2008USA010135: