chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Anxiety, Circumstance or information capable of leading to medication error
Clinical narrative: Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant mostly experiencing anxiety; This spontaneous report was received from a medical assistant referring to herself as a female patient of unknown age. The patient allergy to sulfa, azithromycin, clindamycin, amoxicillin and unspecified antibiotics. The patient had medical history of rash and stomach upset to unspecified antibiotics. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).     On 09-JAN-2020, the patient (medical assistant) was completing vaccination with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # S017244, expiration date 01-DEC-2020), the vaccine sprayed in a mist onto the patient's (medical assistant) hands, face, possibly eyes (occupational exposure to product, accidental exposure to product, exposure via eye contact and exposure via skin contact). The patient mostly experiencing anxiety. The patient did not sought medical attention and there was no laboratory tests were performed for the event. The outcome of anxiety was reported as recovering. Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA003657:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This spontaneous report was received from an other health professional and a lawyer, referring to a 82 year old female patient with abstains from alcohol, abstains from recreational drugs and caffeine consumption. The patient was allergic to lisinopril and quinapril (cough). The patient's family medical history included father (died from pneumonia ), mother (renal failure, hypertension, died from snake bite), brother (diabetes, hypertension, died), sister (kidney transplant). The patient's medical history included cigarettes smoker and chicken pox. Historical vaccines included varicella vaccine. The patient's concomitant medication was not reported.   On 09-SEP-1999 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, strength, batch/lot# and expiration date unknown). On 15-FEB-2005 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, strength, batch/lot# and expiration date unknown). On 26-AUG-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose 0.5ml, lot# R036943 has been verified to be a valid lot number, expiration date 09-APR-2020; route and strength unknown) in the left deltoid (extra dose administered).  The case is linked to case# US-009507513-1812USA001636 and US-009507513-2001USA006254 due to the same patient.; Sender's Comments:  US-009507513-1812USA001636: US-009507513-2001USA006254:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On 30-DEC-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter, for prophylaxis, lot number S013712 has been verified to be valid, expiration date 01-NOV-2020 (strength, route of administration, and anatomical location of vaccination were not provided) (product storage error).   The sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was properly stored.  The temperature of the vaccine administered was reported as -12.2 Celsius degrees (C) and the time frame 25 minutes. Data logger was involved.  There was no previous temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 27-JUL-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately in November 2017 (reported as "within four to five months"), the pt suffered severe and debilitating shingles, rashes and severe pain as a result of the zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to 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, included but not limited to medical losses and costs which included 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. At the time of the report, the outcome of herpes zoster was determined as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event was determined to be serious due to disability.
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Magnetic resonance imaging normal, Seizure
Clinical narrative: Later that evening the patient experienced a seizure and he was taken to an unspecified hospital emergency room by ambulance; an unspecified 27 year old male patient was in the office to receive the 3rd dose of GARDASIL 9; This spontaneous report has been received from an osteopathy physician via a field representative, concerning a 27-year-old male patient. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On an unknown day in December 2019, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 3 dose series (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis (reported as vaccination) (Inappropriate age at vaccine administration).  On an unknown day in December 2019 (reported as later that evening), the patient experienced a seizure and he was taken to an unspecified hospital emergency room by ambulance. A computerised tomogram (CT scan), magnetic resonance imaging (MRI), and 72 hours with continuous monitor electroencephalogram (EEG) were performed. The CT scan and the MRI were negative; and the EEG showed diffuse slowing consistent with seizures. He was seen by the physician since the occurred event and was recovered. No additional adverse events were reported. There was no overdose reported.  The causality assessment between of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the seizure was not provided.  Upon internal review, the event seizure was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 17-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 20-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call  was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254: US-009507513-2001USA009189:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to the patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 27-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On  06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: the patient "reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm".; the patient "reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm".; This spontaneous report was received from a physician , concerning a 61-years-old male patient. The patient's concurrent conditions included type 2 diabetes mellitus, hyperlipidaemia, benign prostatic hypertrophy, and blood pressure high. His concomitant therapies were unknown by the reporter. The patient had no known drug allergies.  On 21-JAN-2020, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection,  intramuscularly, in left deltoid, as prophylaxis (reported as "age dependent vaccine") (strength was not reported; lot number S005856 has been verified to be a valid lot number for pneumococcal Vaccine, Polyvalent (23-valent) with expiration date: 03-DEC-2020).  On 24-JAN-2020, the patient reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm (injection site reaction). It was reported that no laboratory diagnostics or studies were performed. However, the patient sought medical attention, and the physician recommended ibuprofen at a dose of 800 mg, three times per day, and if it did not resolve, the physician told the patient to go to urgent care or emergency room. At the reporting time, the patient had not recovered from injection site pain and injection site reaction; and the patient had not required hospitalization due to the events.   The causal relationship between the aforementioned events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  It was reported that injection site reaction and injection site pain were not cancerous, disabling or life-threatening events.   Physician requested a lot check; therefore a lot investigation has been initiated.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 year old patient received gardasil 9; No additional adverse effects reported; This spontaneous report was received from an office manager via company representative refers to a 55-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), first dose (strength, dose, route, anatomical location, lot/batch # and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse effects were reported (no adverse event). No product quality complaint (PQC) was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing loss; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 08-MAR-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date (reported as "shortly after"), the pt suffered hearing loss (deafness). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered serious, severe, progressive, permanent and incurable personal injuries that caused physical limitations (physical impairment) not presented prior vaccination; the pt also suffered significant conscious pain, suffering, mental anguish, loss of enjoyment of life and emotional distress due to his physical limitations and seriousness of his condition. As a further proximate result, the pt has suffered significant medical expenses, the loss of accumulations and other economic and non-economic damages.  The causality was reported as related and the event was considered to be disabling.  Upon internal review, the pt's deafness was determined to be a medically significant event.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Immediate post-injection reaction, Surgery, Tinnitus
Clinical narrative: immediate and permanent hearing loss; constant tinnitus; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 72-year-old male patient. Medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2011, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot # and expiration date were not provided).  On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): immediate and permanent hearing loss, as well as constant tinnitus and balance issues resulting in surgery and extensive medical care. The patient claimed damages as a result of: injury to themselves and loss of services. The outcome of the events of immediate and permanent hearing loss and constant tinnitus was reported as not recovered. The outcome of the event of balance issues was not provided. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX). The event of immediate and permanent hearing loss was considered to be disabling. Upon internal review, the event of immediate and permanent hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Headache
Clinical narrative: dangerous and painful symptoms; Headaches; ears ringing; uncontrollable shivers; back pain; joint pain; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach. On an unknown date, the outcome of the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient get vaccine and it was the most painful injection followed by all the side affects . The reporter telling everyone about the dangerous side affects. The patient experienced  headache, ears ringing, uncontrollable shivers, back pain, joint pain, upset stomach going on two days. The patient could not get the second shot and should not have to pay and the insurance should not be charged.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Tinnitus
Clinical narrative: dangerous and painful symptoms; Headaches; ears ringing; uncontrollable shivers; back pain; joint pain; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach. On an unknown date, the outcome of the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient get vaccine and it was the most painful injection followed by all the side affects . The reporter telling everyone about the dangerous side affects. The patient experienced  headache, ears ringing, uncontrollable shivers, back pain, joint pain, upset stomach going on two days. The patient could not get the second shot and should not have to pay and the insurance should not be charged.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and experienced hives across her chest and back. Reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Swelling
Clinical narrative: Muscle pain; swelling; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unspecified day the patient received 1st dose wth no reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle pain and swelling. On an unknown date, the outcome of the muscle pain and swelling were unknown.   It was unknown if the reporter considered the muscle pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced muscle pain and swelling during 3 months after vaccination. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Knee arthroplasty
Clinical narrative: Knee Replacement; first dose of Shingrix vaccine on June 26, 2019; This case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th October 2019, 105 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced knee replacement (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the knee replacement and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the knee replacement to be related to Shingrix.  Additional details were reported as follows: The patient went through a knee replacement surgeryafter administraion of 1st dose of Shingrix vaccine. The reason for knee replacement surgery was not reported. The patient was hospitalized for 2 days. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up. The age at vaccination for 2nd dose ofShingrix vaccine could not be deleted due to unexpected behavior.
Age: 2.0
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 year old received adult tetanus; No reactions experienced; MassBiologics received a report from a healthcare professional on 01/09/2019 that a 2 year old child received an injection of Td (identified as NDC: 13533-131-00 but lot # not reported).  The reporter confirmed that the patient did not experience any adverse reactions after Td administration.  The reporter would not provide any further details regarding the patient or the administration error.  During follow-up on 01/17/2019, the physician indicated the child "should not have received any vaccinations" but declined from providing any further information.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered to a patient that was under the labeled age for the product.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Blood test normal, Chills, Headache, Malaise, Nausea
Clinical narrative: chills; fever; headaches; Nausea; general feeling of unwellness; A 54-year-old male received MassBiologics Td vaccine (Lot # A115A1) on 3/25/19 at an urgent care facility for wound prophylaxis. A few hours post vaccination, the patient experienced chills, fever, headache, nausea, and a general feeling of unwellness, with the nausea resolving same day.  During follow-up performed 2-months post vaccination, the patient indicated the chills and fever resolved within 12 to 15 days post vaccination but that he is still experiencing headaches.  The patient reported that he visited his primary care physician (PCP) twice for the headaches (dates unknown) and that blood work and other unspecified testing resulted in normal findings; his PCP has not be able to provided him with a cause for his headaches and they remain unresolved.; Sender's Comments: All adverse events in this case were assessed as non-serious and labeled.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: chills; fever; headaches; Nausea; general feeling of unwellness; A 54-year-old male received MassBiologics Td vaccine (Lot # A115A1) on 3/25/19 at an urgent care facility for wound prophylaxis. A few hours post vaccination, the patient experienced chills, fever, headache, nausea, and a general feeling of unwellness, with the nausea resolving same day.  During follow-up performed 2-months post vaccination, the patient indicated the chills and fever resolved within 12 to 15 days post vaccination but that he is still experiencing headaches.  The patient reported that he visited his primary care physician (PCP) twice for the headaches (dates unknown) and that blood work and other unspecified testing resulted in normal findings; his PCP has not be able to provided him with a cause for his headaches and they remain unresolved.; Sender's Comments: All adverse events in this case were assessed as non-serious and labeled.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Immunisation, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: local reaction of pain at the ID administration site; local reaction of redness at the ID administration site; local reaction that was warm to the touch; intradermal administration of Td instead of PPD; On 10/22/2019 a 21-year-old female mistakenly received an ID injection of MassBiologics' Td (Lot #A102B1) in her right lower forearm instead of a PPD administration; the dose administered was 0.1mL and not the 0.5mL labeled Td dose.  On the same day the patient also received Sanofi Pasteur's Tdap vaccine (Lot #U6214AA) via IM injection in her right deltoid.  The error was found on 10/23/2019 at which time the reporter called the patient reschedule the PPD.  During the call the patient reported redness and pain at the ID administration site.  That same day, the patient returned to the healthcare facility to receive PPD injection and examination of wrong drug reaction.  The patient presented in the office with a local reaction of redness that was warm to the touch at the lower right forearm location where Td was incorrectly administered.  The patient was not treated for the reaction.  The patient returned to the medical facility on 10/25/2019 but there was no record of her Td reaction and the healthcare provider indicated that they had no plans for additional follow up with the patient.  The medical facility also indicated that the wrong drug administration was due to human error.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered in error instead of PPD.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Local reaction, Wrong product administered
Clinical narrative: local reaction of pain at the ID administration site; local reaction of redness at the ID administration site; local reaction that was warm to the touch; intradermal administration of Td instead of PPD; On 10/22/2019 a 21-year-old female mistakenly received an ID injection of MassBiologics' Td (Lot #A102B1) in her right lower forearm instead of a PPD administration; the dose administered was 0.1mL and not the 0.5mL labeled Td dose.  On the same day the patient also received Sanofi Pasteur's Tdap vaccine (Lot #U6214AA) via IM injection in her right deltoid.  The error was found on 10/23/2019 at which time the reporter called the patient reschedule the PPD.  During the call the patient reported redness and pain at the ID administration site.  That same day, the patient returned to the healthcare facility to receive PPD injection and examination of wrong drug reaction.  The patient presented in the office with a local reaction of redness that was warm to the touch at the lower right forearm location where Td was incorrectly administered.  The patient was not treated for the reaction.  The patient returned to the medical facility on 10/25/2019 but there was no record of her Td reaction and the healthcare provider indicated that they had no plans for additional follow up with the patient.  The medical facility also indicated that the wrong drug administration was due to human error.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered in error instead of PPD.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient reports achiness in her joints that she has never had before, since the onset of the Shingrix series.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: Felt off with poor appetite night of vaccine. Woke up the next am with fever 99.9. Arm sore at site
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to  a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pain, Pruritus
Clinical narrative: large area of intense swelling; large area of intense redness; large area of intense pain; very itchy; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, 2 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix 4 days ago the actual injection site was not sore at all but two days ago a large area of intense redness, swelling and pain well below the injection site (at least 3 inches below) developed. It covers a large swath of arm going almost all the way around patient arm above patient elbow. It was also very itchy. Other side effects were manageable but this one was concerning in lie of 2nd injection in a few months.