chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 28-FEB-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 27-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 01-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The nurse reported a dialysis patient was accidentally administered a dose of PNEUMOVAX 23 by intravenous route into their dialysis fistula; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the dialysis patient was accidentally administered  a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot number R022879 and expiration date on 02-AUG-2020, by intravenous route in the dialysis fistula, for prophylaxis (dose and dose number were not reported) (incorrect route of product administration). No adverse effect were reported.
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Chest X-ray normal, Depression, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Syringomyelia/ Syringobulbia; Suicide attempt; Memory loss; Blood clot; Depression; Osteoarthritis of spine; Weight loss; Ended up getting 5 anthrax shots within a few months; Fainting; Little muscle pains; Aches/ pains; Information received on 25/JUN/2019 from: a consumer.   A 43-year-old male consumer (weight: 197 lbs/ 89 kg and height: 6'1" inch) experienced Syringomyelia/ Syringobulbia, Inappropriate schedule of vaccine administered, memory loss, suicide attempt, blood clot, aches/pains, little muscle pains, fainting, depression, osteoarthritis of spine, and weight loss, following the administration of BioThrax intramuscularly.  In Dec 1998 and Jan 1999, the consumer received 2 shots of anthrax vaccine, but these were not put in his medical records. After his return in Feb 1999, the vaccine was restarted. He received three shots at 0, 2, and 4 weeks, respectively. He received total 5 shots and the last one was administered in Apr 1999. Later, he had a PPD (purified protein derivative) reaction after the administration of third anthrax shot. He had a chest X-ray which was negative for tuberculosis. He received a 6 months' treatment with Isoniazid (INH) as a precautionary measure and had chest x-ray every year. The patient also attempted suicide on 07-Dec-2010. His memory from the event was not very good as he suffered memory loss. Following his suicide attempt, blood clots were identified which were there even before and for which he was given a blood thinner as treatment. He also took Naproxen for pain at that time. The patient was admitted to mental home for days or weeks. The consumer also experienced pain, little muscle pains, memory loss, fainting, and depression. He took Zoloft in addition to tramadol and marijuana for pain. He was diagnosed with osteoarthritis of the spine at the age of 32 or 33. Later the patient had a Magnetic resonance imaging (MRI) which found a cyst on his spine. The patient was diagnosed with syringomyelia and syringobulbia. These conditions were affecting him from his head to his butt bone. Recently, he had also been experiencing weight loss (about 30-40 lbs). Outcome of the events were unknown.  Treatments included: Blood thinner for blood clot, naproxen for pain, Zoloft in addition to tramadol and marijuana for pain.  Relevant laboratory / Diagnostics: He had a chest X-ray, scan, and MRI. Chest X-ray: tuberculosis-negative. MRI: cyst on his spine   The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.; Sender's Comments: The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain, Scan, Spinal osteoarthritis, Suicide attempt
Clinical narrative: Syringomyelia/ Syringobulbia; Suicide attempt; Memory loss; Blood clot; Depression; Osteoarthritis of spine; Weight loss; Ended up getting 5 anthrax shots within a few months; Fainting; Little muscle pains; Aches/ pains; Information received on 25/JUN/2019 from: a consumer.   A 43-year-old male consumer (weight: 197 lbs/ 89 kg and height: 6'1" inch) experienced Syringomyelia/ Syringobulbia, Inappropriate schedule of vaccine administered, memory loss, suicide attempt, blood clot, aches/pains, little muscle pains, fainting, depression, osteoarthritis of spine, and weight loss, following the administration of BioThrax intramuscularly.  In Dec 1998 and Jan 1999, the consumer received 2 shots of anthrax vaccine, but these were not put in his medical records. After his return in Feb 1999, the vaccine was restarted. He received three shots at 0, 2, and 4 weeks, respectively. He received total 5 shots and the last one was administered in Apr 1999. Later, he had a PPD (purified protein derivative) reaction after the administration of third anthrax shot. He had a chest X-ray which was negative for tuberculosis. He received a 6 months' treatment with Isoniazid (INH) as a precautionary measure and had chest x-ray every year. The patient also attempted suicide on 07-Dec-2010. His memory from the event was not very good as he suffered memory loss. Following his suicide attempt, blood clots were identified which were there even before and for which he was given a blood thinner as treatment. He also took Naproxen for pain at that time. The patient was admitted to mental home for days or weeks. The consumer also experienced pain, little muscle pains, memory loss, fainting, and depression. He took Zoloft in addition to tramadol and marijuana for pain. He was diagnosed with osteoarthritis of the spine at the age of 32 or 33. Later the patient had a Magnetic resonance imaging (MRI) which found a cyst on his spine. The patient was diagnosed with syringomyelia and syringobulbia. These conditions were affecting him from his head to his butt bone. Recently, he had also been experiencing weight loss (about 30-40 lbs). Outcome of the events were unknown.  Treatments included: Blood thinner for blood clot, naproxen for pain, Zoloft in addition to tramadol and marijuana for pain.  Relevant laboratory / Diagnostics: He had a chest X-ray, scan, and MRI. Chest X-ray: tuberculosis-negative. MRI: cyst on his spine   The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.; Sender's Comments: The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.
Sex: M
Vaccine: ANTH
Symptoms: Syncope, Syringomyelia, Thrombosis, Tuberculin test positive, Weight decreased
Clinical narrative: Syringomyelia/ Syringobulbia; Suicide attempt; Memory loss; Blood clot; Depression; Osteoarthritis of spine; Weight loss; Ended up getting 5 anthrax shots within a few months; Fainting; Little muscle pains; Aches/ pains; Information received on 25/JUN/2019 from: a consumer.   A 43-year-old male consumer (weight: 197 lbs/ 89 kg and height: 6'1" inch) experienced Syringomyelia/ Syringobulbia, Inappropriate schedule of vaccine administered, memory loss, suicide attempt, blood clot, aches/pains, little muscle pains, fainting, depression, osteoarthritis of spine, and weight loss, following the administration of BioThrax intramuscularly.  In Dec 1998 and Jan 1999, the consumer received 2 shots of anthrax vaccine, but these were not put in his medical records. After his return in Feb 1999, the vaccine was restarted. He received three shots at 0, 2, and 4 weeks, respectively. He received total 5 shots and the last one was administered in Apr 1999. Later, he had a PPD (purified protein derivative) reaction after the administration of third anthrax shot. He had a chest X-ray which was negative for tuberculosis. He received a 6 months' treatment with Isoniazid (INH) as a precautionary measure and had chest x-ray every year. The patient also attempted suicide on 07-Dec-2010. His memory from the event was not very good as he suffered memory loss. Following his suicide attempt, blood clots were identified which were there even before and for which he was given a blood thinner as treatment. He also took Naproxen for pain at that time. The patient was admitted to mental home for days or weeks. The consumer also experienced pain, little muscle pains, memory loss, fainting, and depression. He took Zoloft in addition to tramadol and marijuana for pain. He was diagnosed with osteoarthritis of the spine at the age of 32 or 33. Later the patient had a Magnetic resonance imaging (MRI) which found a cyst on his spine. The patient was diagnosed with syringomyelia and syringobulbia. These conditions were affecting him from his head to his butt bone. Recently, he had also been experiencing weight loss (about 30-40 lbs). Outcome of the events were unknown.  Treatments included: Blood thinner for blood clot, naproxen for pain, Zoloft in addition to tramadol and marijuana for pain.  Relevant laboratory / Diagnostics: He had a chest X-ray, scan, and MRI. Chest X-ray: tuberculosis-negative. MRI: cyst on his spine   The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.; Sender's Comments: The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Pain in extremity, Pyrexia
Clinical narrative: stomach cramp; pain in arm; fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received Shingles vaccine. On 14th May 2019, 1 days after receiving Shingles vaccine, the patient experienced stomach cramps. In May 2019, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm, fever and stomach cramps were unknown.   It was unknown if the reporter considered the pain in arm, fever and stomach cramps to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after receiving Shingles vaccine, arm was sore and had a fever. On the date of reporting, the patient stated having severe stomach cramps. The patient asked whether the events occurred are normal or not.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: muscle stiffness; severe shivering; fever; aches and pains; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 10 hrs after receiving Shingrix, the patient experienced muscle stiffness, shivering, fever and pain. On an unknown date, the outcome of the muscle stiffness, shivering, fever and pain were unknown.   It was unknown if the reporter considered the muscle stiffness, shivering, fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had severe muscle stiffness about 10 hours after vaccination which was tolerable. A few hours after vaccination patient experienced severe shivering, fever, and aches. The patient was afraid to have a 2nd injection because of more severe reaction. The patient asked is there anything to prevent a repeat of reactions. The patient also asked do I have a slight immunity to shingles with one injection. The patient stated that, I had a bad reaction with the first injection, am I more or less likely to have a repeat reaction.
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Fever; Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm, fever and myalgia. On an unknown date, the outcome of the pain in arm, fever and myalgia were unknown.   It was unknown if the reporter considered the pain in arm, fever and myalgia to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Medical Assistant reported that she had patients that experienced sore arm, fever, myalgia upon having received a dose of Bexsero.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: tired; itchy rash on arm; Drug dose administration interval too short; Chills; Aches; feeling like they have a virus; sleepy; no energy; fever; sweating; queasy stomach; This case was reported by a physician via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 23rd April 2019 refer case US2019079110).   On 20th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, several hours after receiving Shingrix, the patient experienced chills, pain, fever, sweating, queasy, viral infection, sleepiness and loss of energy. On 20th May 2019, the patient experienced drug dose administration interval too short. On 21st May 2019, the patient experienced itchy rash. On an unknown date, the patient experienced tiredness. The patient was treated with antihistamine (Antihistamines). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The physician reported that his patient had a prolonged reaction to Shingrix after receiving the second dose. A few hours after receiving the dose the patient develop a fever of 101 degree F, chills, sweating, aches and a queasy stomach.  One day after the vaccination, the patient reported developing an itchy rash on the Left arm but not near the injection site. The rash measured 3 by 2 inch and was not resolved with antihistamines.  The patient has continued to complain of chills, sweats feeling like they have a virus, they are tired, sleepy with no energy.  The physician monitoring the patient was ongoing. No additional details provided at the time of report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Rash pruritic, Somnolence
Clinical narrative: tired; itchy rash on arm; Drug dose administration interval too short; Chills; Aches; feeling like they have a virus; sleepy; no energy; fever; sweating; queasy stomach; This case was reported by a physician via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 23rd April 2019 refer case US2019079110).   On 20th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, several hours after receiving Shingrix, the patient experienced chills, pain, fever, sweating, queasy, viral infection, sleepiness and loss of energy. On 20th May 2019, the patient experienced drug dose administration interval too short. On 21st May 2019, the patient experienced itchy rash. On an unknown date, the patient experienced tiredness. The patient was treated with antihistamine (Antihistamines). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The physician reported that his patient had a prolonged reaction to Shingrix after receiving the second dose. A few hours after receiving the dose the patient develop a fever of 101 degree F, chills, sweating, aches and a queasy stomach.  One day after the vaccination, the patient reported developing an itchy rash on the Left arm but not near the injection site. The rash measured 3 by 2 inch and was not resolved with antihistamines.  The patient has continued to complain of chills, sweats feeling like they have a virus, they are tired, sleepy with no energy.  The physician monitoring the patient was ongoing. No additional details provided at the time of report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Viral infection
Clinical narrative: tired; itchy rash on arm; Drug dose administration interval too short; Chills; Aches; feeling like they have a virus; sleepy; no energy; fever; sweating; queasy stomach; This case was reported by a physician via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 23rd April 2019 refer case US2019079110).   On 20th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, several hours after receiving Shingrix, the patient experienced chills, pain, fever, sweating, queasy, viral infection, sleepiness and loss of energy. On 20th May 2019, the patient experienced drug dose administration interval too short. On 21st May 2019, the patient experienced itchy rash. On an unknown date, the patient experienced tiredness. The patient was treated with antihistamine (Antihistamines). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the chills, pain, tiredness, fever, sweating, queasy, itchy rash, viral infection, sleepiness and loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The physician reported that his patient had a prolonged reaction to Shingrix after receiving the second dose. A few hours after receiving the dose the patient develop a fever of 101 degree F, chills, sweating, aches and a queasy stomach.  One day after the vaccination, the patient reported developing an itchy rash on the Left arm but not near the injection site. The rash measured 3 by 2 inch and was not resolved with antihistamines.  The patient has continued to complain of chills, sweats feeling like they have a virus, they are tired, sleepy with no energy.  The physician monitoring the patient was ongoing. No additional details provided at the time of report.
Sex: F
Vaccine: FLUX
Symptoms: Chronic fatigue syndrome
Clinical narrative: Chronic fatigue syndrome; This case was reported by a consumer via call center representative and described the occurrence of chronic fatigue syndrome in a 67-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included depression. Previously administered products included Prozac (started to receive at the age of 50 years).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced chronic fatigue syndrome. On an unknown date, the outcome of the chronic fatigue syndrome was recovered/resolved.   It was unknown if the reporter considered the chronic fatigue syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The patient had experienced depression periodically throughout her entire life but as she started taking Prozac at 50 years old, she had not been depressed since.  The age at vaccination was not reported but it could be 56 years or 57 years. 10 years ago from the date of reporting, the patient experienced chronic fatigue syndrome after getting a flu vaccine. She did not remember what flu vaccine it was.  It took 9 months to recover from the fatigue. The patient also received Shingrix and experienced some adverse events, refer case US2019116950 reported by the same reporter. The patient did not consent to follow up. There is a discrepancy with respect to the outcome of the event chronic fatigue syndrome. In source document, the outcome is reported as recovered/resolved with sequel, however as per narrative description it is recovered/resolved. The outcome of the event retains as per the narrative description.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Inappropriate schedule of vaccine; Vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2019, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2018, about 6 to 8 weeks later of receiving 1st dose, the patient received the 2nd dose of Shingrix.  The patient received 2nd dose earlier than the dosing recommendation of Shingrix, which led to shortening of vaccination schedule.  About 4 days ago (from the date of reporting), the patient developed Shingles. The patient was very frustrated and did not provide any further details.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event, peds dose given and should have given patient an adult dose. Used VFC stock because patient had insurance (not realizing he was over 18) and did not realize it was also peds dose. Patient is an adult and should have received an adult size dose
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Mom reports began to have fever of 103 degrees and nausea and vomiting off and on until 2 pm next day. Denies any rash, anaphylactic symptoms, or any local injection site issues
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Hypopnoea, Nausea, Pain
Clinical narrative: dizzy; whole body soreness / soreness; shallow breathing; nausea/nauseated; Labored breathing; This case was reported by a physician via sales rep and described the occurrence of dizziness in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX797AA, expiry date unknown) for prophylaxis.   On 26th March 2019, the patient received the 1st dose of Bexsero. On 26th March 2019, 4 hrs after receiving Bexsero, the patient experienced dizziness, general body pain, shallow breathing, nausea and labored breathing. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dizziness, general body pain, shallow breathing, nausea and labored breathing were recovering/resolving.   The reporter considered the dizziness, general body pain, shallow breathing, nausea and labored breathing to be probably related to Bexsero.  Additional details were reported as follows: The patient received  a dose of Bexsero on the left deltoid. Four to five hours (also discrepantly reported as within 4 to 5 hours) after vaccination, the patient experienced whole body soreness, dizzy, nauseated (did not throw up), labored breathing and shallow breathing. A clarification request had been raised to confirm time to onset for events. The patient did not experience cough and fever. The patient took Tylenol and then went to sleep.  Next day, the patient still had little sore, 1 to 2 hours later felt dizzy again.  The patient took Tylenol and 4 hours later, the patient felt better. The physician felt that, the patient's experience was most likely caused by the Bexsero and that she was hesitant to administer the 2nd dose. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Oral herpes
Clinical narrative: I woke up in the morning with diaherrea and a huge cold sore on my bottom lip.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Full blood count, Laboratory test normal, Pain
Clinical narrative: Fever 102F, body aches, chills, Fatigue. He took tylenol and helped fever. Fever free 7/10/19 today without medication use.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102F, body aches, chills, Fatigue. He took tylenol and helped fever. Fever free 7/10/19 today without medication use.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, stomach ache , nausea and pain at site
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Age: 36.0
Sex: U
Vaccine: MEN
Symptoms: Dry eye, Lymphadenopathy, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: low grade fever; lymph nodes swelled; eyes got dryer; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a 36-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced low grade fever, enlargement of lymph nodes, eye dryness and inappropriate age at vaccine administration. On an unknown date, the outcome of the low grade fever, enlargement of lymph nodes and inappropriate age at vaccine administration were unknown and the outcome of the eye dryness was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, enlargement of lymph nodes and eye dryness to be related to Meningococcal B vaccine.  Additional details were provided as follows: At the age of 36 the patient went to the school to receive a dose of Meningococcal B vaccine, which led to an incorrect age at vaccine administration. The patient was misinformed and was told that the patient had to have it. The patient developed very low grade fever and every single one of lymph nodes were swelled and also noticed shortly after this that eyes got dryer and still to this day, the patient suffer with dry eyes and can no longer wear contacts. The patient inquired, how to remove the effects of this vaccine out of the patient's body.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Nausea
Clinical narrative: Nausea; Swollen area; Redness; Welting/red welts; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced nausea, injection site swelling, injection site erythema and injection site wheal. On an unknown date, the outcome of the nausea, injection site swelling, injection site erythema and injection site wheal were unknown.   It was unknown if the reporter considered the nausea, injection site swelling, injection site erythema and injection site wheal to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix in the left deltoid and experienced nausea and swollen red welting area at the site of injection site. The patient came into the pharmacy at the time of reporting and the swollen red area has moved half way between the site of injection and above the elbow.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Headache, Nasal congestion
Clinical narrative: Body  aches, splitting headache, tremors (shivering), fever, lethargy, stuffy nose, slight stomach upset, loss of appetite.  Duration 24 hours
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Body  aches, splitting headache, tremors (shivering), fever, lethargy, stuffy nose, slight stomach upset, loss of appetite.  Duration 24 hours
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Second shot produced red rash in area opposite of injection site on same arm, first shot with no rash reaction, but first shot caused feeling under the weather/achey x 2 days, no achiness with second shot, just red rash, raised area, about 2 days later to present
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed soreness and redness in upper arm in the evening after receiving the immunization earlier in the afternoon. The redness got worse and patient had a liitle pain radiating behind arm. Patient used ice for the swelling but did not really help. The patient came into pharmacy on 7-9-2019 and a slightly raised, warm to touch red area on upper arm was noticed. He went to see his physician on advisement on 7-9-2019 and was diagnosed with cellulitis and prescribed an oral antibiotic. The doctor told patient that he probably developed this condition due to the injection. The patient was told that if he wasn't better by 7-12-2019 then the doctor would admit him into the hospital for IV antibiotics.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient developed soreness and redness in upper arm in the evening after receiving the immunization earlier in the afternoon. The redness got worse and patient had a liitle pain radiating behind arm. Patient used ice for the swelling but did not really help. The patient came into pharmacy on 7-9-2019 and a slightly raised, warm to touch red area on upper arm was noticed. He went to see his physician on advisement on 7-9-2019 and was diagnosed with cellulitis and prescribed an oral antibiotic. The doctor told patient that he probably developed this condition due to the injection. The patient was told that if he wasn't better by 7-12-2019 then the doctor would admit him into the hospital for IV antibiotics.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient woke up this morning 07/10/2019 09:00AM with a very sore left arm and limited arm mobility Redness to the site of injection, patient states some swelling.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site bruising, Injection site rash, Injection site reaction, Malaise
Clinical narrative: Severe 4? x 2? rash about 2? from injection site.  GP sent me to medi clinic to see if it was cellulitis.  That Dr said it appeared to be  severe injection  reaction, even though it was 2? lower on arm than injection spot.  It turnd into bruising, and is still slightly visible 18 days later.  The rash was very painful and i did het a headache and not feel well for 3 days after shot.  I will not do the 2nd shot