chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: Does not fell well; Feels like she has a virus "under her skin"; Skin on both the arms hurt; pain/ pain also involves her left hip; Burning sensation/ burning sensation from her spine to the belly button; Diagnosis of ulcerative colitis; Diagnosed as shingles/shingles presented in the left side of her body; Rash-like presentation; This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, 20 days after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the patient experienced ulcerative colitis (serious criteria GSK medically significant), feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation. The patient was treated with mesalazine (Apriso). On an unknown date, the outcome of the ulcerative colitis, rash, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the ulcerative colitis, rash, shingles, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of the Shingrix vaccine and experienced rash like presentation, which was diagnosed as shingles, which was confirmed with a lab test. She did not have blisters with the shingles. The shingles presented in the left side of her body. The patient stated that her shingles had resolved but she generally did not feel well. She felt like she had a virus under her skin. The patient felt like the skin on both the arms hurt. The pain also involved her left hip and also burning sensation from her spine to the belly button. She had diagnosed with ulcerative colitis and took Apriso for the diagnosis. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Feeling abnormal, Herpes zoster, Laboratory test abnormal
Clinical narrative: Does not fell well; Feels like she has a virus "under her skin"; Skin on both the arms hurt; pain/ pain also involves her left hip; Burning sensation/ burning sensation from her spine to the belly button; Diagnosis of ulcerative colitis; Diagnosed as shingles/shingles presented in the left side of her body; Rash-like presentation; This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, 20 days after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the patient experienced ulcerative colitis (serious criteria GSK medically significant), feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation. The patient was treated with mesalazine (Apriso). On an unknown date, the outcome of the ulcerative colitis, rash, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the ulcerative colitis, rash, shingles, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of the Shingrix vaccine and experienced rash like presentation, which was diagnosed as shingles, which was confirmed with a lab test. She did not have blisters with the shingles. The shingles presented in the left side of her body. The patient stated that her shingles had resolved but she generally did not feel well. She felt like she had a virus under her skin. The patient felt like the skin on both the arms hurt. The pain also involved her left hip and also burning sensation from her spine to the belly button. She had diagnosed with ulcerative colitis and took Apriso for the diagnosis. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain of skin, Rash
Clinical narrative: Does not fell well; Feels like she has a virus "under her skin"; Skin on both the arms hurt; pain/ pain also involves her left hip; Burning sensation/ burning sensation from her spine to the belly button; Diagnosis of ulcerative colitis; Diagnosed as shingles/shingles presented in the left side of her body; Rash-like presentation; This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, 20 days after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the patient experienced ulcerative colitis (serious criteria GSK medically significant), feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation. The patient was treated with mesalazine (Apriso). On an unknown date, the outcome of the ulcerative colitis, rash, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the ulcerative colitis, rash, shingles, feeling unwell, feeling abnormal, skin pain, pain in hip and burning sensation to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of the Shingrix vaccine and experienced rash like presentation, which was diagnosed as shingles, which was confirmed with a lab test. She did not have blisters with the shingles. The shingles presented in the left side of her body. The patient stated that her shingles had resolved but she generally did not feel well. She felt like she had a virus under her skin. The patient felt like the skin on both the arms hurt. The pain also involved her left hip and also burning sensation from her spine to the belly button. She had diagnosed with ulcerative colitis and took Apriso for the diagnosis. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Condition aggravated, Erythema, Essential tremor, Headache
Clinical narrative: facial redness/ my face was bright red like bad sunburn; chills; my pulse went much higher than normal; shaking/ leg shaking/worsened tremor; aching/soreness; heart pounding; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2021) for prophylaxis.   The patient's past medical history included tremor and red face. Previously administered products included Shingrix (1st dose received on 12th November 2019), cortisone and epinephrine. Concomitant products included potassium nos (Potassium) and simvastatin.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction. On 22nd January 2020, the patient experienced heart pounding and red face. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the pulse increased, adverse event and allergic reaction were unknown and the outcome of the tremor, pain, heart pounding, red face and chills were recovering/resolving.   It was unknown if the reporter considered the pulse increased, tremor, pain, heart pounding, red face, chills, adverse event and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction,heart pounding, red face after receiving 2nd dose of Shingrix. For tolerance with 1st dose of Shingrix refer linked case.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Middle insomnia, Myalgia, Nausea, Pain in extremity
Clinical narrative: facial redness/ my face was bright red like bad sunburn; chills; my pulse went much higher than normal; shaking/ leg shaking/worsened tremor; aching/soreness; heart pounding; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2021) for prophylaxis.   The patient's past medical history included tremor and red face. Previously administered products included Shingrix (1st dose received on 12th November 2019), cortisone and epinephrine. Concomitant products included potassium nos (Potassium) and simvastatin.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction. On 22nd January 2020, the patient experienced heart pounding and red face. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the pulse increased, adverse event and allergic reaction were unknown and the outcome of the tremor, pain, heart pounding, red face and chills were recovering/resolving.   It was unknown if the reporter considered the pulse increased, tremor, pain, heart pounding, red face, chills, adverse event and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction,heart pounding, red face after receiving 2nd dose of Shingrix. For tolerance with 1st dose of Shingrix refer linked case.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: facial redness/ my face was bright red like bad sunburn; chills; my pulse went much higher than normal; shaking/ leg shaking/worsened tremor; aching/soreness; heart pounding; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2021) for prophylaxis.   The patient's past medical history included tremor and red face. Previously administered products included Shingrix (1st dose received on 12th November 2019), cortisone and epinephrine. Concomitant products included potassium nos (Potassium) and simvastatin.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction. On 22nd January 2020, the patient experienced heart pounding and red face. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the pulse increased, adverse event and allergic reaction were unknown and the outcome of the tremor, pain, heart pounding, red face and chills were recovering/resolving.   It was unknown if the reporter considered the pulse increased, tremor, pain, heart pounding, red face, chills, adverse event and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction,heart pounding, red face after receiving 2nd dose of Shingrix. For tolerance with 1st dose of Shingrix refer linked case.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Heart rate increased, Hypersensitivity, Pain
Clinical narrative: facial redness/ my face was bright red like bad sunburn; chills; my pulse went much higher than normal; shaking/ leg shaking/worsened tremor; aching/soreness; heart pounding; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2021) for prophylaxis.   The patient's past medical history included tremor and red face. Previously administered products included Shingrix (1st dose received on 12th November 2019), cortisone and epinephrine. Concomitant products included potassium nos (Potassium) and simvastatin.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction. On 22nd January 2020, the patient experienced heart pounding and red face. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the pulse increased, adverse event and allergic reaction were unknown and the outcome of the tremor, pain, heart pounding, red face and chills were recovering/resolving.   It was unknown if the reporter considered the pulse increased, tremor, pain, heart pounding, red face, chills, adverse event and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction,heart pounding, red face after receiving 2nd dose of Shingrix. For tolerance with 1st dose of Shingrix refer linked case.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor
Clinical narrative: facial redness/ my face was bright red like bad sunburn; chills; my pulse went much higher than normal; shaking/ leg shaking/worsened tremor; aching/soreness; heart pounding; This case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2021) for prophylaxis.   The patient's past medical history included tremor and red face. Previously administered products included Shingrix (1st dose received on 12th November 2019), cortisone and epinephrine. Concomitant products included potassium nos (Potassium) and simvastatin.   On 21st January 2020, the patient received the 1st dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction. On 22nd January 2020, the patient experienced heart pounding and red face. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the pulse increased, adverse event and allergic reaction were unknown and the outcome of the tremor, pain, heart pounding, red face and chills were recovering/resolving.   It was unknown if the reporter considered the pulse increased, tremor, pain, heart pounding, red face, chills, adverse event and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pulse increased, tremor, pain, chills, adverse event and allergic reaction,heart pounding, red face after receiving 2nd dose of Shingrix. For tolerance with 1st dose of Shingrix refer linked case.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mental disorder
Clinical narrative: Mental Blur; This case was reported by a consumer via call center representative and described the occurrence of mental disorder in a female patient who received Herpes zoster (Shingrix) (batch number 3C3Y4, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date, she was fine).   On 13th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, 2 days after receiving Shingrix, the patient experienced mental disorder. On an unknown date, the outcome of the mental disorder was recovering/resolving.   It was unknown if the reporter considered the mental disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 15th January 2020, the patient noted she was in mental blurr, which she further explained as just out of it. At the time of reporting, the patient was not perfect but was doing better. On 17th January 2020, the patient felt better. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness transient, Hallucination, Mobility decreased, Muscle tightness, Mydriasis
Clinical narrative: Extreme pain Hallucinating Psychogenic non epileptic seizures Temporary blindness Muscle tensing
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Seizure, Viral infection
Clinical narrative: Extreme pain Hallucinating Psychogenic non epileptic seizures Temporary blindness Muscle tensing
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: lhe patient was vaccinated wilh improperly stored M­R II on 03JAN2020; The patient did not experience any symptoms; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical condition and current condition were unknown.  On 03-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (1 dose, lot # S004118, expiration date: 11-FEB-2021; route unknown) for prophylaxis with sterile diluent. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to temperature of 72.5 degree Fahrenheit for 10 minutes and 51.4 degree Fahrenheit for 2 hours and 4 minutes previously, and the data logger was involved. The sterile diluent was not reported as improperly stored. The patient did not experience any symptoms. The outcome of events was unknown.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: multiple transient ischemic attack; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a 74 years old  male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 20-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for prophylaxis. As a result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer multiple transient ischaemic attack with the first took place on 24-SEP-2017, including any and all of their sequelae. As a result, the patient suffered from severe personal injuries, pain and emotional distress, as well as to incur substancial economic damages.    The outcome of transient ischaemic attack was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of transient ischaemic attack was considered to be medically significant.  .
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Coma, Fatigue, Heart injury, Hypoxia
Clinical narrative: Respiratory distress and failure; Respiratory distress and failure; Hypoxia; Coma; Infection of unknown origins; Rashes and lesions on her skin; Weakness and fatigue; Cardiac injuries; Weakness and fatigue; Rashes and lesions on her skin; extremely high fever; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Within approximately 10 days of receiving zoster vaccine live (ZOSTAVAX) vaccine, on 15-JUN-2012, the pt suffered life threatening injuries which began with extremely high fever (pyrexia) and infection of unknown origins accompanied by rashes and lesions on her skin (skin lesion) and severe weakness (asthenia) and fatigue. The infectious state and fever caused respiratory distress, respiratory failure and hypoxia resulting in admission to Intensive Care Unit (ICU) hospitalization for 10 days in a debilitated/comatose state (coma). She also suffered cardiac injuries (heart injury). All of these injuries were caused by zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations (disabling seriousness) not present prior to using the product. Additionally, pt also experienced mental and emotional distress due to this limitations and seriousness of her condition. Pt sustained severe and debilitating personal injuries and in addition, suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, pt was not recovered from the events.  Upon internal review, coma, heart injury, hypoxia, respiratory failure and respiratory distress were considered medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Intensive care, Pyrexia, Rash, Respiratory distress
Clinical narrative: Respiratory distress and failure; Respiratory distress and failure; Hypoxia; Coma; Infection of unknown origins; Rashes and lesions on her skin; Weakness and fatigue; Cardiac injuries; Weakness and fatigue; Rashes and lesions on her skin; extremely high fever; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Within approximately 10 days of receiving zoster vaccine live (ZOSTAVAX) vaccine, on 15-JUN-2012, the pt suffered life threatening injuries which began with extremely high fever (pyrexia) and infection of unknown origins accompanied by rashes and lesions on her skin (skin lesion) and severe weakness (asthenia) and fatigue. The infectious state and fever caused respiratory distress, respiratory failure and hypoxia resulting in admission to Intensive Care Unit (ICU) hospitalization for 10 days in a debilitated/comatose state (coma). She also suffered cardiac injuries (heart injury). All of these injuries were caused by zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations (disabling seriousness) not present prior to using the product. Additionally, pt also experienced mental and emotional distress due to this limitations and seriousness of her condition. Pt sustained severe and debilitating personal injuries and in addition, suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, pt was not recovered from the events.  Upon internal review, coma, heart injury, hypoxia, respiratory failure and respiratory distress were considered medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory failure, Skin lesion
Clinical narrative: Respiratory distress and failure; Respiratory distress and failure; Hypoxia; Coma; Infection of unknown origins; Rashes and lesions on her skin; Weakness and fatigue; Cardiac injuries; Weakness and fatigue; Rashes and lesions on her skin; extremely high fever; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Within approximately 10 days of receiving zoster vaccine live (ZOSTAVAX) vaccine, on 15-JUN-2012, the pt suffered life threatening injuries which began with extremely high fever (pyrexia) and infection of unknown origins accompanied by rashes and lesions on her skin (skin lesion) and severe weakness (asthenia) and fatigue. The infectious state and fever caused respiratory distress, respiratory failure and hypoxia resulting in admission to Intensive Care Unit (ICU) hospitalization for 10 days in a debilitated/comatose state (coma). She also suffered cardiac injuries (heart injury). All of these injuries were caused by zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations (disabling seriousness) not present prior to using the product. Additionally, pt also experienced mental and emotional distress due to this limitations and seriousness of her condition. Pt sustained severe and debilitating personal injuries and in addition, suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, pt was not recovered from the events.  Upon internal review, coma, heart injury, hypoxia, respiratory failure and respiratory distress were considered medically significant events.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects.; an unspecified two week old patient was inadvertently administered one dose of ROTATEQ along with five other unspecified GSK vaccines; This spontaneous report has been received from a physician referring to a 2 week old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (indication, strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis ( product administered to patient of inappropriate age).  On the same date, the patient was vaccinated with other unspecified GSK vaccines. No additional adverse effects.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: patient that received dose of MMR II began to experience joint pain in the hands and knees; This spontaneous report has been received from a nurse concerning a 52-year-old female patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were unknown by the reporter.    On 11-DEC-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (recombinant human albumin) (M-M-R II) for immunization, 1 dosage form via subcutaneous on her right upper arm (concentration and frequency of vaccination scheme were not reported). Lot number S010706 has been verified to be a valid lot number, expiration date reported and validated as 08-APR-2021.  On 18-DEC-2019, the patient began to experience joint pain in the hands and knees (arthralgia). It was reported that the patient did not seek medical attention and that no treatment was given for the event, but the reported did not know if any laboratory tests were performed.      At the time of reporting, the patient had not recovered from the joint pain in the hands and knees.   The causal relationship Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and joint pain in the hands and knees was not 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 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 S010727 and expiration date 26-JUL-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 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 S010727 and expiration date 27-JUL-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 31-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 S023499 and expiration date 24-AUG-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: PPV
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 19-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-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: PPV
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), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-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: PPV
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 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-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: PPV
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 13-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-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 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:
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 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:
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 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 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:
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 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  S023499 and expiration date 24-AUG-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 31-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 S023499 and expiration date 08-AUG-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 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 S023499 and expiration date 24-AUG-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: PPV
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), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-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: F
Vaccine: VARZOS
Symptoms: Pneumonia, Traumatic lung injury
Clinical narrative: infection of the lungs, pneumonia; respiratory injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On 13-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). On an unspecified date in November 2017, reported as within ten days after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an infection of lungs, pneumonia and other life threatening respiratory injuries resulting in hospitalization. These conditions resulted in prolonged medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries and disfigurement not present prior to using the zoster vaccine live (ZOSTAVAX), which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries, the patient suffered serious, progressive, 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 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 of pneumonia and respiratory injuries were reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia and respiratory injuries were considered to be disabling and life threatening. Upon internal review, the event of pneumonia was considered to be medically significant.