chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Fatigue, Influenza like illness, Vaccination failure
Clinical narrative: Pharmacy administered pneumonia, flu / flu like symptomssuspected vaccination failure; flu like symptoms; felt extremely rundown; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml, Influenza vaccine Quadrivalent unspecified season and Pneumococcal vaccine. On an unknown date, not applicable after receiving Shingrix and Pneumococcal vaccine and less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza-like symptoms and tiredness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza-like symptoms and tiredness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Pneumococcal vaccine. It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The patient's demographics were not reported. The pharmacy administered pneumonia, flu and Shingrix  vaccine at the same time to the patient and patient felt extremely rundown with flu like symptoms for multiple days. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not agree to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: sore in the deltoid muscle; This case was reported by a physician and described the occurrence of muscle soreness in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in August 2020, refer case US2020204752).   On 12th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th October 2020, 5 hrs after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and half a day after he experienced sore in the deltoid muscle. The reporter did not consent to follow-up. This case has been linked with US2020204756 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204756:same reporter (wife´s case) US-GLAXOSMITHKLINE-US2020204752:same patient, 1st dose
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Confusional state, Dizziness, Incoherent, Loss of consciousness, Nausea
Clinical narrative: Fainted; nauseous; Felt faint; very pale; Incoherent; Confused; Clearing throat multiple times; This case was reported by a nurse via call center representative and described the occurrence of fainting in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H535B, expiry date 25th September 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 3X2KX, expiry date 30th June 2021) for prophylaxis.   Previously administered products included Dtap vaccine (received on an unknown date) and Flu vaccine (received on an unknown date).   On 12th October 2020, the patient received Boostrix (intramuscular) and FluLaval Tetra 2020-2021 season. On 12th October 2020, less than a day after receiving Boostrix and FluLaval Tetra 2020-2021 season and an unknown time after starting Albuterol, the patient experienced fainting (serious criteria GSK medically significant), nausea, felt faint, pallor, incoherent, confusion and throat clearing. The patient was treated with salbutamol sulphate (Albuterol), dexamethasone and oxygen. On 12th October 2020, the outcome of the fainting and felt faint were recovered/resolved. On an unknown date, the outcome of the nausea, pallor, incoherent, confusion and throat clearing were unknown.   It was unknown if the reporter considered the fainting, nausea, felt faint, pallor, incoherent, confusion and throat clearing to be related to Boostrix and FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient after receiving both vaccines felt nauseous ,faint, and very pale. She fainted and came to 1 to 2 minutes later. After coming, she was incoherent, confused and clearing her throat multiple times. Albuterol dexamethasone and oxygen administered. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pallor, Syncope, Throat clearing
Clinical narrative: Fainted; nauseous; Felt faint; very pale; Incoherent; Confused; Clearing throat multiple times; This case was reported by a nurse via call center representative and described the occurrence of fainting in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H535B, expiry date 25th September 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 3X2KX, expiry date 30th June 2021) for prophylaxis.   Previously administered products included Dtap vaccine (received on an unknown date) and Flu vaccine (received on an unknown date).   On 12th October 2020, the patient received Boostrix (intramuscular) and FluLaval Tetra 2020-2021 season. On 12th October 2020, less than a day after receiving Boostrix and FluLaval Tetra 2020-2021 season and an unknown time after starting Albuterol, the patient experienced fainting (serious criteria GSK medically significant), nausea, felt faint, pallor, incoherent, confusion and throat clearing. The patient was treated with salbutamol sulphate (Albuterol), dexamethasone and oxygen. On 12th October 2020, the outcome of the fainting and felt faint were recovered/resolved. On an unknown date, the outcome of the nausea, pallor, incoherent, confusion and throat clearing were unknown.   It was unknown if the reporter considered the fainting, nausea, felt faint, pallor, incoherent, confusion and throat clearing to be related to Boostrix and FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient after receiving both vaccines felt nauseous ,faint, and very pale. She fainted and came to 1 to 2 minutes later. After coming, she was incoherent, confused and clearing her throat multiple times. Albuterol dexamethasone and oxygen administered. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both doses of Shingrix and still developed Shingles / Shingles is ongoing / suspected vaccination failure; received both doses of Shingrix and still developed Shingles / Shingles is ongoing; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported for 2nd dose. The patient received both doses of Shingrix and still developed Shingles. No health factors, concomitant medications or specific date when the infection began was given. The outbreak of Shingles was ongoing. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 7RK76 to 7RK7K.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: violently ill; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA290167 (same reporter).  This case involves a patient of an unknown demographic who was violently ill (malaise), when received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination respectively.  On an unknown date, the patient was violently ill (malaise) (non-serious, Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  There will be no information on the batch number of this case.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states that his left arm is very sore and cannot move it.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 7 hours after vaccine: Fever up 102.4, Chills/terrible shaking for more than 30 minutes, Pain in feet (7/10), Lightheadedness, Headache, Fatigue Next morning: Pain in feet moved up to above my knees, lightheadedness, overall achiness, headache, fever, fatigue, took Theraflu and symptoms were better Next morning (2 days after vaccine): Low-grade fever (99.0), terrible neck pain and stiffness, mostly resolved by the next day
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: 7 hours after vaccine: Fever up 102.4, Chills/terrible shaking for more than 30 minutes, Pain in feet (7/10), Lightheadedness, Headache, Fatigue Next morning: Pain in feet moved up to above my knees, lightheadedness, overall achiness, headache, fever, fatigue, took Theraflu and symptoms were better Next morning (2 days after vaccine): Low-grade fever (99.0), terrible neck pain and stiffness, mostly resolved by the next day
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: 7 hours after vaccine: Fever up 102.4, Chills/terrible shaking for more than 30 minutes, Pain in feet (7/10), Lightheadedness, Headache, Fatigue Next morning: Pain in feet moved up to above my knees, lightheadedness, overall achiness, headache, fever, fatigue, took Theraflu and symptoms were better Next morning (2 days after vaccine): Low-grade fever (99.0), terrible neck pain and stiffness, mostly resolved by the next day
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Vomiting
Clinical narrative: Mother reported client vomiting 2 hours after vaccination of influenza around 10:15 a.m. on 10/16/2020.  Mother reported no other symptoms at that time.   Mother was advised of other symptoms of allergic reaction and to seek medical attention.  Mother reported later that day on Friday she started with rash all over her body.  Mother took client to Urgent care.  Dr. voiced possible allergic reaction to influenza or possibility client was coming down with virus before vaccination and vaccination exacerbated symptoms.  Client was given IV fluids, antihistamine.  Unsure of other treatments.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Poor feeding infant, Rash, Screaming, Somnolence, Trance
Clinical narrative: After the injection was given, my daughter let out a high pitched wail. 10 minutes after we left the doctors office she looked like she was in a trance. She then slept for the rest of the morning, afternoon and only nursed one time despite multiple offerings of the breast. The next day her face began to break out and by the end of the week it was a full body rash. I took her to the pediatrician again on 10/09/2020 and showed her rash to the physician. They didn?t have a diagnosis for her skin but recommended that I keep her moisturized. I have to apply aquafor several times a day and her skin is still dry to the touch and rough. This is not normal. Nothing in our routine has changed so this sudden rash is extremely worrisome.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: pt complained of an itchy rash that was on her stomach and back
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Wife of the patient called and stated that the patient could not lift his right arm. He noticed some moderate soreness that started a few  hours after the injection. He stated that he can move his arm some but has a lot of soreness and feel like he cant raise his arm very well. I counseled the patient to contact his MD if this continues or gets worse. He stated the arm is not swollen or red. The patient said he is taking Ibuprofen and using a heating pad.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Swelling, redness, hardness of entire upper arm for 3 days after injection. Soreness to left arm continues. Numbness of lips, left cheek and ear lobe.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site swelling
Clinical narrative: Swelling, redness, hardness of entire upper arm for 3 days after injection. Soreness to left arm continues. Numbness of lips, left cheek and ear lobe.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: approximately 6 cm wheal on left upper arm at vaccine site hives on torso, legs, chest, back treatment: prednisone, diphenhydramine, Reglan, cetirizine
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Food craving, Gait disturbance, Head discomfort, Headache, Nausea
Clinical narrative: severe headache and pressure in head, reduction in vision in both eyes but especially the left eye, vertigo which caused walk to be crooked and some walking into walls, nausea and felt need for starchy fools, high fever for several days which came and went over the course of a day.  Symptoms lessened slowly over one week period.  Today, one week after the injections, still have mild headache and vertigo and slept 11 hrs last night, straight through.  Nausea is gone.  Still feeling some fever, very mild, off and on.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia, Vertigo, Visual impairment
Clinical narrative: severe headache and pressure in head, reduction in vision in both eyes but especially the left eye, vertigo which caused walk to be crooked and some walking into walls, nausea and felt need for starchy fools, high fever for several days which came and went over the course of a day.  Symptoms lessened slowly over one week period.  Today, one week after the injections, still have mild headache and vertigo and slept 11 hrs last night, straight through.  Nausea is gone.  Still feeling some fever, very mild, off and on.
Age: 59.0
Sex: F
Vaccine: IPV, MNQ, PPV
Symptoms: Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Pt c/o severe pain, swelling, and redness in left arm starting several hours after vaccination that was unrelieved by analgesics.  Progressed to low-grade temperature, chills, and fatigue an hour after noticing marked swelling and pain.  Symptoms lasted for over 36 hours until resolving around 48 hours after injection, to nearly completely resolving 72 hours after injection.
Age: 59.0
Sex: F
Vaccine: IPV, MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: Pt c/o severe pain, swelling, and redness in left arm starting several hours after vaccination that was unrelieved by analgesics.  Progressed to low-grade temperature, chills, and fatigue an hour after noticing marked swelling and pain.  Symptoms lasted for over 36 hours until resolving around 48 hours after injection, to nearly completely resolving 72 hours after injection.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Employee feels that injection was given too high and posterior to correct placement in deltoid.  She noticed a tingling sensation, pain and numbness within a few hours after receiving the injection.  These symptoms continue today. Employee does not plan to seek treatment at this time.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Skin tightness
Clinical narrative: Patient arrived to clinic to receive flu vaccine. He stated he has not had a problem with the flu vaccine in the past, but gets faint with "shots." The head of bed was lowered prior to vaccine administraition. Approximately 5-10 minutes after vaccination, the patient complained of tightening in his hands, abdomen, and legs tightening. Two liters of oxygen via nasal cannula given to patient and patient O2 sat increased to 100% and stayed at 100% after oxygen stopped. EMS was called and patient was transported to ED.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swollen, red, tender.   Parent said they gave the child Tylenol before getting shot
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Patient reports itching beginning 10/16/20 on the left arm, which intensified over the weekend with small, red bumps appearing the evening of 10/17. She stated the bumps are localized around the site of injection, but said she had NO issues/injection site reaction prior to 10/16. She also received Flucelvax last year with no complications. She has not had an office visit YET but will be contacting her physician.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: 10-15-20/  severe pain in left arm suddenly  at 20:00hr; B/ 175/84, hr 51,  lasted most of the night, settled in the morning, this is the pain I had after a day taking my first Levaquin,  These episodes persisted through evening of 10-16;  10/17, until yesterday 10/18, when the pain was less in the evening, heart rate not as high 162/72, alway decreasing after taking my evening heart meds.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Headache, Pain
Clinical narrative: Terrible pains all over My body and joins, headache, fever, stomach upset.no desire to eat, arm swollen, Happened  a few hours After the injection. At the same time and in the same arm, a pneumonia shot is injected as well.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Terrible pains all over My body and joins, headache, fever, stomach upset.no desire to eat, arm swollen, Happened  a few hours After the injection. At the same time and in the same arm, a pneumonia shot is injected as well.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: vaccine injected into my bursa sac in my shoulder and not in my deltoid muscle
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Back pain, Erythema, Grip strength decreased, Infection
Clinical narrative: Severe pain in upper right arm. Unable to lift arm fully starting Tuesday night. Mild fever started Tuesday evening increased to 102 on Wednesday and Thursday. Pain in arm began moving lower in muscle on Thursday including new redness goind down my arm and away from injection site and skin was sore to the touch similar to a sunburn. I went to urgent care and they diagnosed me with an infection. Fever had subsided slightly by then but returned to nearly 102 later that night. Started anti-biotics Thursday evening and by Saturday I finally started getting some relief. No fever after Saturday but arm was very weak. Could not hold my cell phone or do any regular lifting or use of my arm. Had cold feelings in waves inside my arm and down the side of my arm Saturday. On Sunday, strength seemed a little better but I had to keep my arm in a resting position on my leg or by laying down or I would experience sharp pains in my shoulder and back similar to over exertion. Today (Monday) right shoulder is sore, under my arm is sore and still feel some pain in back shoulder blade and some soreness in my right pec. Arm is still weak. No fever since Saturday. Still taking anti-biotics for another 4 days. I contacted pharmacy and they were less than interested in hearing these issues.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Muscular weakness, Musculoskeletal chest pain
Clinical narrative: Severe pain in upper right arm. Unable to lift arm fully starting Tuesday night. Mild fever started Tuesday evening increased to 102 on Wednesday and Thursday. Pain in arm began moving lower in muscle on Thursday including new redness goind down my arm and away from injection site and skin was sore to the touch similar to a sunburn. I went to urgent care and they diagnosed me with an infection. Fever had subsided slightly by then but returned to nearly 102 later that night. Started anti-biotics Thursday evening and by Saturday I finally started getting some relief. No fever after Saturday but arm was very weak. Could not hold my cell phone or do any regular lifting or use of my arm. Had cold feelings in waves inside my arm and down the side of my arm Saturday. On Sunday, strength seemed a little better but I had to keep my arm in a resting position on my leg or by laying down or I would experience sharp pains in my shoulder and back similar to over exertion. Today (Monday) right shoulder is sore, under my arm is sore and still feel some pain in back shoulder blade and some soreness in my right pec. Arm is still weak. No fever since Saturday. Still taking anti-biotics for another 4 days. I contacted pharmacy and they were less than interested in hearing these issues.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pain, Pain in extremity, Pain of skin, Peripheral coldness
Clinical narrative: Severe pain in upper right arm. Unable to lift arm fully starting Tuesday night. Mild fever started Tuesday evening increased to 102 on Wednesday and Thursday. Pain in arm began moving lower in muscle on Thursday including new redness goind down my arm and away from injection site and skin was sore to the touch similar to a sunburn. I went to urgent care and they diagnosed me with an infection. Fever had subsided slightly by then but returned to nearly 102 later that night. Started anti-biotics Thursday evening and by Saturday I finally started getting some relief. No fever after Saturday but arm was very weak. Could not hold my cell phone or do any regular lifting or use of my arm. Had cold feelings in waves inside my arm and down the side of my arm Saturday. On Sunday, strength seemed a little better but I had to keep my arm in a resting position on my leg or by laying down or I would experience sharp pains in my shoulder and back similar to over exertion. Today (Monday) right shoulder is sore, under my arm is sore and still feel some pain in back shoulder blade and some soreness in my right pec. Arm is still weak. No fever since Saturday. Still taking anti-biotics for another 4 days. I contacted pharmacy and they were less than interested in hearing these issues.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Severe pain in upper right arm. Unable to lift arm fully starting Tuesday night. Mild fever started Tuesday evening increased to 102 on Wednesday and Thursday. Pain in arm began moving lower in muscle on Thursday including new redness goind down my arm and away from injection site and skin was sore to the touch similar to a sunburn. I went to urgent care and they diagnosed me with an infection. Fever had subsided slightly by then but returned to nearly 102 later that night. Started anti-biotics Thursday evening and by Saturday I finally started getting some relief. No fever after Saturday but arm was very weak. Could not hold my cell phone or do any regular lifting or use of my arm. Had cold feelings in waves inside my arm and down the side of my arm Saturday. On Sunday, strength seemed a little better but I had to keep my arm in a resting position on my leg or by laying down or I would experience sharp pains in my shoulder and back similar to over exertion. Today (Monday) right shoulder is sore, under my arm is sore and still feel some pain in back shoulder blade and some soreness in my right pec. Arm is still weak. No fever since Saturday. Still taking anti-biotics for another 4 days. I contacted pharmacy and they were less than interested in hearing these issues.
Age: 2.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after injections, parent called pediatricians office with concerns about warmth, redness, pain, and swelling at the injection site. Pt came in for exam and was noted to have 7-8 cm diameter of erythema to right thigh. He  was diagnosed with cellulitis and given Keflex for 5 days
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Adrenal disorder, Blood test, Cardiovascular evaluation, Central nervous system function test, Computerised tomogram
Clinical narrative: PASSED OUT DURING NITE WHEN UP TO GO TO BATHROOM--WAS ON FLOOR TILL 10:00AM NEXT AM..WAS NOT ALERT-TALKING SENSE-WAS ABULANCED TO HOSPITAL AND THERE 5 DAYS--TESTED FOR EVERY THING AND FOUND ADRENAL GLANDS NOT PUMPING REGULARLY--NOTHING ELSE FOUND.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Laboratory test, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: PASSED OUT DURING NITE WHEN UP TO GO TO BATHROOM--WAS ON FLOOR TILL 10:00AM NEXT AM..WAS NOT ALERT-TALKING SENSE-WAS ABULANCED TO HOSPITAL AND THERE 5 DAYS--TESTED FOR EVERY THING AND FOUND ADRENAL GLANDS NOT PUMPING REGULARLY--NOTHING ELSE FOUND.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Developmental regression, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Serum Sickness (Hypersensitivity) High fever at 103, urticaria beginning in lymph area then moving to a widespread bordered dark red rash over entire body.  Regression with walking, increased falling, trouble walking and frequently seeking comfort for pain.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Serum sickness, Urticaria
Clinical narrative: Serum Sickness (Hypersensitivity) High fever at 103, urticaria beginning in lymph area then moving to a widespread bordered dark red rash over entire body.  Regression with walking, increased falling, trouble walking and frequently seeking comfort for pain.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 05-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 24-AUG-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 25-AUG-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-AUG-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2020 , the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 03-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 89-year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-SEP-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter felt the events were related to the suspect vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: get sick after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got sick.
Sex: U
Vaccine: FLUX, PPV, TDAP, VARZOS
Symptoms: Fatigue, Influenza like illness, Vaccination failure
Clinical narrative: Pharmacy administered shingrix with the flu / flu like symptoms; flu like symptoms; felt extremely rundown; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and pneumonia shot for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix .5 ml, Tdap Vaccine and pneumonia shot at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Shingrix and Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza-like symptoms and fatigue. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza-like symptoms and fatigue to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix and Tdap Vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received Shingrix with the flu, pneumonia and Tdap all at the same time and patient felt extremely rundown and experienced flu like symptoms for multiple days following. This case was considered as suspected vaccination failure for flu vaccine as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 93FR9, expiry date 29th April 2022) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix and was tired. The reporter consented to follow up. For tolerance of 2nd dose refer cases US2020203956.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203956:Same reporter