chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no effects noted; a patient received an expired MMR II; This spontaneous report was received from a medical assistant and refers to a 4-year-old male, patient. The patient's concurrent condition included eczema. The patient had no known drug allergies. His historical vaccines included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid, diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified), Hib conj vaccine (tet toxoid), pneumococcal conj vaccine (unspecified), pneumococcal 13v conj vaccine, rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) and varicella virus vaccine live (unspecified). His concomitant therapies included diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (KINRIX), varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent. On 07-JAN-2020, the patient was vaccinated with expired second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml, subcutaneously in left thigh, lot # N032750, expiration date not reported but upon internal validation established as 20-NOV-2019 for prophylaxis. The person that was preparing the vaccination missed number 19 in the expiration date field and thought that NOV20 meant November 2020. The patient did not experience any adverse event.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Inadvertently administered a dose of properly stored proquad; This spontaneous report was received from a nurse referring to a 1-year-old female patient. Patient's concurrent conditions, medical history, drug allergy/reaction and concomitant medications were not reported. On 20-JAN-2020, the patient was inadvertently administered a dose of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S017255, expiry date: 01-DEC-2020, therapy type: recombinant human albumin (rHA) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with the properly stored varicella virus vaccine live (oka/merck) (VARIVAX) Lot# S019583, expiry date: 25-JUN-2021 (strength, formulation, dose. Frequency, route were unknown) for prophylaxis (wrong product administered). The vaccine was reconstituted with properly stored sterile diluent. No adverse effect was reported. The outcome of wrong product administered and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Herpes zoster, Pain of skin, Pneumonia
Clinical narrative: Pneumonia; Post herpetic neuralgia; Herpes zoster; 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 15-APR-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as "shortly after", the pt suffered from a productive cough, shortness of breath and generalized joint pain and was diagnosed with pneumonia. The pt also experienced skin severe pain along with rash/lesions and was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Furthermore, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of pneumonia, herpes zoster and post herpetic neuralgia was reported as not recovered. The lawyer considered pneumonia, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant. Additionally, the events were determined to be serious due to disability.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Productive cough, Rash, Skin lesion
Clinical narrative: Pneumonia; Post herpetic neuralgia; Herpes zoster; 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 15-APR-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as "shortly after", the pt suffered from a productive cough, shortness of breath and generalized joint pain and was diagnosed with pneumonia. The pt also experienced skin severe pain along with rash/lesions and was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Furthermore, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of pneumonia, herpes zoster and post herpetic neuralgia was reported as not recovered. The lawyer considered pneumonia, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant. Additionally, the events were determined to be serious due to disability.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: The patient did not experience any symptoms; did not receive a full dose of PROQUAD; This spontaneous report was received from a registered nurse, concerning a 4 year old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.   On 23-JAN-2020, the patient did not receive a full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, dose number, route of administration and anatomical location were not reported) (lot # S013711 and expiration date on 01-NOV-2020) administered for prophylaxis. The patient did not experience any symptoms.   Since the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  sprayed in the physician's eye during the administration the case MARRS # 2001USA008752 was also created.; Sender's Comments:  US-009507513-2001USA008704:
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 03-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: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 24-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from a rash with severe pain, burning and itching all over the anterior abdominal wall on the right side. The patient was diagnosed with herpes zoster and post herpetic trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered/not resolved. The reporter felt both events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 24-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from a rash with severe pain, burning and itching all over the anterior abdominal wall on the right side. The patient was diagnosed with herpes zoster and post herpetic trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered/not resolved. The reporter felt both events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash, Rash erythematous
Clinical narrative: rash all over her body; red bumps; dose 2 was given on january 12, 2020. Three days later; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in July 2019).   On 12th January 2020, the patient received the 2nd dose of Shingrix. On 12th January 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th January 2020, the patient experienced generalized rash and red rash. On an unknown date, the outcome of the generalized rash, red rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the generalized rash and red rash to be related to Shingrix.  Additional details were provided as follows: On 12th January 2020, the patient received the 2nd dose of Shingrix late, which led to lengthening of the vaccination schedule.  Three day later patient reports she was experiencing a rash all over body, except for her face. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: vaccine was administered in gluteus instead of deltoid, NO AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old female patient who was vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] in the gluteus instead of deltoid muscle on an unspecified date.  Medical history included raccoon bite. Past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included IMMUNOGLOBULIN HUMAN ANTI-RABIES (Imogam)  On an unspecified date, patient t was vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] via unknown route in gluteus site instead of deltoid (day 3 and day 7 dose).    It was a case of actual medication error due to vaccine administered at inappropriate site.   At the time of report, no adverse event was reported.   Laboratory data was not provided.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 year old patient received two doses of Menactra within 5 months, no AE; Initial information received on 14-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received two dosing of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via unknown route in unknown administration site on 20-Aug-2019 and on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was also a case of actual medication error due to extra dose administered. It was reported that at the time they did not know that the child previously had vaccine back on 8/20/2019. if the child will be okay after receiving 2 vaccines within 5 months. The child received their first Menactra vaccine on 4/2015.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old infant received a dose of Fluzone Quadrivalent in error, no AE.; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a two months old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error (lot UT6713LA and expiration date not reported) via intramuscular route in the right thigh on 21-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error case due to Inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Headache, Throat tightness
Clinical narrative: Patient received vaccination and was asked to remain in the pharmacy waiting area for approximately 15 minutes following administration. After about 10 to 15 minutes, patient approached pharmacist complaining of throat tightness, chest tightness, and headache. Patient was advised to be seated in the waiting area. A second pharmacist as well as the store manager waited with the patient while the Immunizing pharmacist called 9-1-1. An epinephrine pen along with aspirin tablets were made available in case the symptoms worsened, but were not administered. Paramedics arrived on the scene within 10 minutes of contacting 9-1-1. Paramedics evaluated the patient in the pharmacy waiting area and then escorted patient to their on-site ambulance for further tests/evaluation. Patient was not transported off of store property by the paramedics. Patient was able to return home of his own accord. Immunizing pharmacist called patient to follow-up on 1/18/20. Patient reported that the throat and chest tightness had both been resolved/gone away within 30 minutes from the start of those symptoms. Patient reported that the headache he experienced did not resolve until 1 to 2 days after vaccination occurred. Patient reported that he did not seek further examination or follow-up with a physician, emergency, or urgent care following vaccination episode and that he currently felt that he had returned to his "normal" health.
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PT DID NOT HAVE ADVERSE REATION TO VACCINES.  THEY WERE ADMINISTERED AT 45 DAY INTERVAL INSTEAD OF 60 DAYS.  PT RECEIVED PPSV23 AND SHINGRIX #2 ON 1/7/2020, FOLLOWING PCV13 AND SHINGRIX #1 ON 11/26/19.     PCV13-PPSV23 INTERVAL WAS SHORTER THAN RECOMMENDED, BUT OK SINCE PT TOLERATED.   WILL NEED PPSV23 IN 5 YEARS.   SHINGRIX #1-2 INTERVAL WAS ALSO SHORTER THAN RECOMMENDED.  CONSIDER "VALID DOSE" AROUND MONTH 6 (MAY 2020).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash, Urticaria
Clinical narrative: PATIENT STATES THAT ON 1/23 HIS INJECTION SITE WAS RED AND ITCHY.THE NEXT DAY HE BROKE OUT IN A RASH/HIVES ON HIS HEAD.SOME OF THEM ON THE LEFT SIDE OF HIS FACE.HE HAS BEEN TAKING BENADRYL AND USED A TOPICAL ITCH CREAM. I TOLD HIM TO MAKE AN APPOINTMENT WITH HIS DOCTOR . PATIENT SAID THERE WAS NO CHANGE IN MEDICATION,DETERGENT OR ANYTHING THAT HE REMEMBERS AROUND THE TIME OF THE VACCINATION.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Pain
Clinical narrative: Fever of 101-104 for more than 24 hours, headache, dizziness, weakness, shivering, achy, shooting pain in right hand
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 101-104 for more than 24 hours, headache, dizziness, weakness, shivering, achy, shooting pain in right hand
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Patient reports two and a half days of severe itching all over body-scalp, neck , palms, and soles of my feet were the worst areas. Reports  got scattered rashes on torso, wrists, and neck, but no hives. Patient reports itching started the day after she received the vaccine,  did not have any trouble breathing, or swelling, or itching of the tongue/mouth; Rash started later that day; reports  took Benadryl  for two days.  Rash resolved after two days still have some itching, mainly at night, on the soles of my feet, with burning when she rubs them.
Age: 96.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Myalgia, Rotator cuff syndrome
Clinical narrative: To date, 1-25-2020 from a day or two after receiving 9-16-2019, the Flu shot, I started having pain in my muscles in my right arm where I got the shot. From then on it got worse and moved to my other arm, my back and legs. During that time I took only one pill a day to relieve the muscle pain, either ALEVE or OBUPROFEN, did not want any side effects from taking too many of those pills. The worse time of the day with the pain is every morning when I wake up and get up, some days for a while two hands to lift a cup of coffee. Now seems to be getting better now after all of this time but I still feel the muscle pain. Went to my regular Dr., and he suggested it was my right rotor cup in my shoulder and suggested I go to Rehabilitation. I am going to go, but do not agree with his thoughts on my problem I think it is some side effect of the Flu shot.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: Fever - Felt Rotten - Drug out - No Energy - Weak
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Subcutaneous injection formulation administered by other route; no additional adverse effect reported; Information has been received from the office manager who was also the Medical Assistant, concerning a 35-year-old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided.  On 21-JAN-2020 the patient was vaccinated with a properly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), (Lot # S024369, expiration date 08-JUN-2021) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (Lot # R033667, expiration date on 14-JUN-2021) (dosage not provided) administered intramuscularly instead of subcutaneously (Incorrect route of product administration).  No additional adverse effect was reported.
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 09-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 aditional 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 10-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 13-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  S002506 and expiration date 04-APR-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:
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Cataract operation, Eye inflammation, Hypoaesthesia, Injected limb mobility decreased, Macular oedema
Clinical narrative: Arm pain became more intense; Decreased mobility in arm has worsened; Decreased mobility in arm that received Td; Injection looked like it was administered in the wrong place, 2 inches below the deltoid; Arm pain in arm that received Td; Numbness in left hand and fingers; Macular swelling in eye that received cataract surgery; Blurry vision in eye that received cataract surgery; A 69-year-old female received MassBiologics' Td vaccine (Lot # A116A2) in her left arm on 10/15/19 at an urgent care facility for wound prophylaxis.  On the same day post vaccination, the patient experienced arm pain and decreased mobility in her left arm with worsening pain and mobility four (4) days post vaccination.  On 10/20/19 the patient sought treatment for the adverse reactions at a different urgent care facility.  During the 10/20 visit, the physician indicated the Td vaccination site may have been approximately two (2) inches below the deltoid (labeled administration site).  Patient did not receive any treatment for the reaction.  The patient reported the event on 11/4/2019 at which time the worsening pain and mobility had resolved but the patient had reported the addition of numbness in her left hand and fingers.  The patient went on to state that she had undergone cataract surgery in one eye during the week prior to receiving the Td vaccination and subsequent cataract surgery in the other eye one week post vaccination.  When reporting of the event, the patient indicated she had experienced macular swelling / inflammation which resulted in blurry vision, but only in the pre-vaccination eye, which lead the patient to feel the events were related to the Td vaccination.  The patient sought treatment and her ophthalmologist prescribed Prolensa and Invetys for the eye condition but did not report any findings from the ophthalmologist regarding a relation between the eye events and Td vaccine.  During follow-up on 12/19/2019, the patient indicated that all reported events had resolved within 6 weeks post Td vaccination.; Sender's Comments: All events were assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Arm pain became more intense; Decreased mobility in arm has worsened; Decreased mobility in arm that received Td; Injection looked like it was administered in the wrong place, 2 inches below the deltoid; Arm pain in arm that received Td; Numbness in left hand and fingers; Macular swelling in eye that received cataract surgery; Blurry vision in eye that received cataract surgery; A 69-year-old female received MassBiologics' Td vaccine (Lot # A116A2) in her left arm on 10/15/19 at an urgent care facility for wound prophylaxis.  On the same day post vaccination, the patient experienced arm pain and decreased mobility in her left arm with worsening pain and mobility four (4) days post vaccination.  On 10/20/19 the patient sought treatment for the adverse reactions at a different urgent care facility.  During the 10/20 visit, the physician indicated the Td vaccination site may have been approximately two (2) inches below the deltoid (labeled administration site).  Patient did not receive any treatment for the reaction.  The patient reported the event on 11/4/2019 at which time the worsening pain and mobility had resolved but the patient had reported the addition of numbness in her left hand and fingers.  The patient went on to state that she had undergone cataract surgery in one eye during the week prior to receiving the Td vaccination and subsequent cataract surgery in the other eye one week post vaccination.  When reporting of the event, the patient indicated she had experienced macular swelling / inflammation which resulted in blurry vision, but only in the pre-vaccination eye, which lead the patient to feel the events were related to the Td vaccination.  The patient sought treatment and her ophthalmologist prescribed Prolensa and Invetys for the eye condition but did not report any findings from the ophthalmologist regarding a relation between the eye events and Td vaccine.  During follow-up on 12/19/2019, the patient indicated that all reported events had resolved within 6 weeks post Td vaccination.; Sender's Comments: All events were assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Rotator cuff syndrome
Clinical narrative: Patient received Shingrix Vaccine, number one, in right arm on 10/25/2019 by CMA.  Patient presented to the office 1/24/2020 to be seen by Dr. for right arm drooping.  Dr. suspects patient may have a rotator cuff injury related to vaccine administration.  He prescribed NSAIDs and referred the patient to sports medicine.  He is looking for their opinion, then will possibly move to MRI.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: PATIENT DEVELOPED RINGING IN EARS ABOUT 48 HOURS AFTER RECEIVING HIS SECOND DOSE OF SHINGRIX.  THE ADVERSE EVENT DISAPPEARED IN ABOUT 3 DAYS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: patient states that right  arm was bruised and sore and unable to lift and very painful.... when viewing clinical services tab under patient profile records state patient received vaccine in left arm
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Patient began noticing soreness and redness in arm same day of injection, symptoms persisted for next three days until patient reported to pharmacy. Redness has extended down from injection site to lower upper arm (down to elbow). Patient using Biofreeze topically with little to no improvement. Advised patient to follow up with physician if redness and soreness is persisting for additional day, or if symptoms worsen in same time frame.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Strong flu like symptoms. No nausea.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Fatigue, Peripheral swelling
Clinical narrative: Tc from client today states arm is swollen the size of a baseball and very red, improving redness today. Also states had severe back pain yesterday "worse than after surgery" and extreme fatigue. Advised to monitor if redness and swelling were increasing and follow up with pc to discuss if should get second dose. Enc ice to site as needed. States back pain has improved but enc to follow up if recurs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: swollen, redness
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore achy arm
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: erythema, heat, tenderness. Treatment is ice application and Tylenol.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient noted erythema, warmth, swelling, and itching approximately 48hrs after injection.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Blood glucose decreased, Crying, Headache, Pallor, Tremor
Clinical narrative: approximately 1-1.5 hours after receiving vaccination, child returned to school based clinic crying, stated " I am shaking all over and have the worst headache I have ever had in my life".  Nurse seated child in chair, noted child was pale and visibly trembling all over her entire body.  Child was not exhbiting any signs of allergic reaction (hives, rash, swelling in face, nose, tongue, or throat) and denied difficulty breathing.  Blood pressure taken, 140/100.  Nurse made decision to call 911.  Cool cloths placed on child's forehead and neck.  Squad arrived at approximately 12:00pm.  Blood pressure 136/78, heart rate 87, blood sugar 124.  Child taken to nearest emergency room by squad, parents notified.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt reported arm redness in a half-band around her arm, warm to the touch, and some swelling starting Sunday night.  Went to primary care provider on 1/27/2020, provider stated the vaccine may have been administered lower than desired or may have hit a vessel, prescribed steroid.  Thursday morning pt reported reduced redness, reduced swelling.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Student RN inadvertently administered Hep A vaccine. Hep A series had already been completed, making this his 3rd dose. Parent notified of mistake.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Vaccine exp date - 12/18/2019
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mental impairment, Migraine, Pain, Pain in extremity
Clinical narrative: Patient states the reaction started the at 9:00am the morning after immunization (1/30/20) She had aches and pains. She could not think or vocalize properly. She had numbness of the hands and developed a migraine.  The symptoms lasted until 3pm, approximately 7 hours.  She did not call or go to Doctor or Emergency room.  She called around 5:30pm and states she is feels fine other then her arm is a little sore.  She did not have any of these symptoms the first shot with the exception of the  arm soreness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder
Clinical narrative: Patient states the reaction started the at 9:00am the morning after immunization (1/30/20) She had aches and pains. She could not think or vocalize properly. She had numbness of the hands and developed a migraine.  The symptoms lasted until 3pm, approximately 7 hours.  She did not call or go to Doctor or Emergency room.  She called around 5:30pm and states she is feels fine other then her arm is a little sore.  She did not have any of these symptoms the first shot with the exception of the  arm soreness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain, Skin warm
Clinical narrative: pt states that she has a red knot in the arm that is hot to the touch, she also reports severe pain lasting 3 days after vaccination
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site pruritus, Injection site vesicles
Clinical narrative: inflammation at site of injection,   raised vesicles appearing, itching.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine had already expired on 01/17/2020 and the Medical Assistant that gave the vaccine did not realize it before she administered it on 01/27/2020. No reaction reported by patient's mother, but Dr. wanted it reported since an expired vaccine was given.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pt states in day following vaccine experiences severe pain in BOTH shoulders, though only received vaccine in Left Shoulder. Difficult for pt to raise BOTH arms above shoulder height. Pain has persisted since vaccination 3 months ago and continues to today.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Gait disturbance, Headache, Nausea
Clinical narrative: Mother reported that patient felt dizzy after receiving the Meningitis vaccine last year.  So prior to administration of vaccine patient was given apple juice to drink and laid down on exam table prior to administration of vaccine.  HPV-9 VIS given and discussed with Mother.  HPV-9 vaccine administered to patient in left deltoid while patient was laying down on exam table and cool compress applied to forehead.  Patient monitored.  Patient reported not feeling well after receiving the vaccine, feeling dizzy.  Patient was examined by Dr., vitals taken, given cool compress for forehead, and given another apple juice.  Patient was monitored further then reported having a headache, feeling nauseous and dizzy again.  Patient examined again by doctor, vitals taken.  Vitals stable. Patient monitored further.  Patient then complained about still feeling lightheaded and not wanting to walk.  Ambulance called for transport to the ER.   Patient in no respiratory distress.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: ongoing pain and limited movement of shoulder
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Mobility decreased, Musculoskeletal stiffness, Pain, X-ray
Clinical narrative: PATIENT HAD PAIN AND FROZEN ARM AND UNABLE TO MOVE THE ARM ABOVE THE SHOULDER BECAUSE OF STIFFNESS AND PAIN
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Right thigh became red around the injection site and continued to spread larger and became super hot to the touch. The evening of the 29th the rash took over her entire right thigh and was stinging. We went to the pediatrician the morning of the 30th and she was placed on an antibiotic because of the severness of the rash and the heat coming from it.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient's wife came in on 1/30/2020 and stated that her husband received his shingrix over the weekend and now has very itchy hives on his arm. She stated his doctor told him to take Benadryl which has helped, and also prescribed him prednisone to take.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count, Pain, Pain in extremity
Clinical narrative: Left arm pain which started shortly after the injection and has continued since, which is 8 days after.  The pain got significantly worse within the first 24 hours, has decreased slightly but still present.  The pain is worse with movement of the arm.  There was no redness, swelling or abscess.  She is being treated with ibuprofen and norco and will follow up in 3 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Left arm pain which started shortly after the injection and has continued since, which is 8 days after.  The pain got significantly worse within the first 24 hours, has decreased slightly but still present.  The pain is worse with movement of the arm.  There was no redness, swelling or abscess.  She is being treated with ibuprofen and norco and will follow up in 3 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia, Vision blurred
Clinical narrative: Bad Chills (did not want to get out of bed in the morning) & Fever up to 102.5 and weak for 48 hours. Periodic headaches from dull to severe for 72 hours.  Occasional quick (not lasting) stomach pain first 12 hours. Cloudy vision morning after for about 20 minutes
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Delirium, Influenza virus test negative, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: red bumpy rash on the tummy, bruise like rash on back, fever currently at 101.4, red throat was tested for flu and strep both came back negative. slight deliriousness, sore through and cough, runny nose.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rhinorrhoea, Streptococcus test negative
Clinical narrative: red bumpy rash on the tummy, bruise like rash on back, fever currently at 101.4, red throat was tested for flu and strep both came back negative. slight deliriousness, sore through and cough, runny nose.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Sore arm ,  fatigue, flu like symptoms,  fever, chills body aches. 2 days
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm ,  fatigue, flu like symptoms,  fever, chills body aches. 2 days
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: & local pain, red, warmth site vaccine
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Mobility decreased
Clinical narrative: Patient had severe nausea, headache, chills, malaise, weakness for 2 days. Those symptoms cleared up after 2 days. patient still having hot, swollen arm which she can barley lift.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Skin warm
Clinical narrative: Patient had severe nausea, headache, chills, malaise, weakness for 2 days. Those symptoms cleared up after 2 days. patient still having hot, swollen arm which she can barley lift.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Balance disorder, Dizziness, Fear, Nervousness
Clinical narrative: Patient was administered below vaccines and about 1 minute later patient started to say she was "dizzy" & slowing losing her balance. Patient was caught and attended by provider and was back to normal state in about 30min. Patient prior to vaccines was scared & nervous. Patient also had not ate.
Age: 69.0
Sex: U
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Pain, Product administered at inappropriate site
Clinical narrative: Injection given in lower r arm. Site of injection throbbing hurting Radiating up arm to shoulder & neck. Seems injection given to low on arm. Injection site throbbing. 11a Injection Site elbow Throbbing at sight of injection. I have been in Physical Therapy. Seems to help some but pain returns. I cannot scratch my left shoulder without pain. Putting clothes over head there is pain. I am going to see an orthopedic physician. I want to know what this is
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Computerised tomogram head abnormal, Dizziness, Skin laceration, Syncope
Clinical narrative: DIZZINESS (+) SYNCOPAL EPISODE x1 w/FACIAL LACERATIONS