chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Patient experienced fevers, slight chills, and a sore, red hardened area (roughly 5" in diameter) at and surrounding the vaccine site injection. General malaise and soreness of the arm lasted several days- a week. Still experiencing some malaise.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Impaired work ability, Joint swelling, Pain, Renal pain
Clinical narrative: Severe kidney pain right knee swelled could not walk. Then left knee. Extreme pain.Still in pain 4 months later still undiagnosed.Unable to work.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Gait inability, Impaired work ability, Joint swelling
Clinical narrative: Severe kidney pain right knee swelled could not walk. Then left knee. Extreme pain.Still in pain 4 months later still undiagnosed.Unable to work.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test normal
Clinical narrative: Severe kidney pain right knee swelled could not walk. Then left knee. Extreme pain.Still in pain 4 months later still undiagnosed.Unable to work.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Severe kidney pain right knee swelled could not walk. Then left knee. Extreme pain.Still in pain 4 months later still undiagnosed.Unable to work.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Whooping cough vaccine. My daughter is pregnant. First the area got extremely sore to touch around 2 inches wide and 6 inches long. Over 2 day it got really red over the same area. Called the doctor six day later and he told me to use benadryl 2 X a day and sent itch cream to the pharmacy. The redness continued to move down my arm to just above my elbow and continues to itch and bright red this is the 8 day since the shot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Mobility decreased, Rash
Clinical narrative: Rash, can't lift arm, heat.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site warmth
Clinical narrative: Allergic RXN at left upper extremity after TDaP six days ago still hot, itchy no lip swelling, no tongue swelling, no difficulty swallowing 14X19cm area of confluent erythema over proximal left upper extremity - Triamcinolone in SARNA Top Lotn - DELTASONE 50 mg Oral Tab 1 tab daily for 5 days  - cool compresses, oral BENADRYL as needed.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Acute disseminated encephalomyelitis, Gait disturbance, Gait inability, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Developed instability and ultimately inability to walk on 2/9/2018 - referred to hospital.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Developed instability and ultimately inability to walk on 2/9/2018 - referred to hospital.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after vaccine developed redness, pain, swelling, heat at site. Seen in office 2/20/19 and prescribed CLARITIN, BENADRYL and prednisone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Blister, Herpes zoster, Influenza like illness, Peripheral swelling
Clinical narrative: One Shingles Blister which itched beginning 2 days after 2nd SHINGRIX injection (May 24, 2018). I have photo. Husband is neurologist. I first thought it could be melanoma which runs in my family so made appointment with plastic surgeon for biopsy May 30. By May 29, 2018, 7 days after the vaccination, it looked like one large blister, rather than a melanoma. The biopsy on May 30, 2018 came back negative. When I showed the photo later to my dermatologist, he confirmed that it was a shingles blister. I also have a photo of the blister from May 29, 2018, 7 days after the 2nd Shingles vaccination. Also, on the first SHINGRIX vaccination, I just had a little soreness at the site. When I had the 2nd vaccination, 61 days after the first, I had large pink swollen arm, flu like symptoms AND the 1 shingles blister which was completely gone by 2 weeks or so. The blister was also on the site of what I call a "barnacle which is a seborrheic keratosis or age spot".
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin reaction
Clinical narrative: One Shingles Blister which itched beginning 2 days after 2nd SHINGRIX injection (May 24, 2018). I have photo. Husband is neurologist. I first thought it could be melanoma which runs in my family so made appointment with plastic surgeon for biopsy May 30. By May 29, 2018, 7 days after the vaccination, it looked like one large blister, rather than a melanoma. The biopsy on May 30, 2018 came back negative. When I showed the photo later to my dermatologist, he confirmed that it was a shingles blister. I also have a photo of the blister from May 29, 2018, 7 days after the 2nd Shingles vaccination. Also, on the first SHINGRIX vaccination, I just had a little soreness at the site. When I had the 2nd vaccination, 61 days after the first, I had large pink swollen arm, flu like symptoms AND the 1 shingles blister which was completely gone by 2 weeks or so. The blister was also on the site of what I call a "barnacle which is a seborrheic keratosis or age spot".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pain, Vomiting
Clinical narrative: 24 hours after 2nd SHINGRIX, pt had flu like symptoms....N&V, diarrhea, ache all over. 1st SHINGRIX, her arm was very achy.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Aldolase normal, Antinuclear antibody negative, Asthenia, Blood creatine phosphokinase normal, Borrelia test negative
Clinical narrative: Pt reported feeling achy all over the day after his flu shot. The following day is legs started to hurt, and the day after that his arms and legs had muscle twitches which persisted. The following day pt had numbness and weakness which resolved later that evening. Pt finally called the office 5 days after the vaccine that he was still having muscle twitching and his legs were going numb again. Pt given appt 23 mins after initial phone call as the weakness persisted, from the office he was sent to the ER, and evaluated there.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Hypoaesthesia, Muscle twitching
Clinical narrative: Pt reported feeling achy all over the day after his flu shot. The following day is legs started to hurt, and the day after that his arms and legs had muscle twitches which persisted. The following day pt had numbness and weakness which resolved later that evening. Pt finally called the office 5 days after the vaccine that he was still having muscle twitching and his legs were going numb again. Pt given appt 23 mins after initial phone call as the weakness persisted, from the office he was sent to the ER, and evaluated there.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Red blood cell sedimentation rate increased, Urine analysis normal
Clinical narrative: Pt reported feeling achy all over the day after his flu shot. The following day is legs started to hurt, and the day after that his arms and legs had muscle twitches which persisted. The following day pt had numbness and weakness which resolved later that evening. Pt finally called the office 5 days after the vaccine that he was still having muscle twitching and his legs were going numb again. Pt given appt 23 mins after initial phone call as the weakness persisted, from the office he was sent to the ER, and evaluated there.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Discomfort, Erythema, Immediate post-injection reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received GARDASIL 9 vaccine IM right deltoid. Usual complaints of discomfort at time of injection. Waited in office 15 minutes after injection and left office without further complaint or concern. Parent called next afternoon saying patient was complaining of right arm redness, pain and swelling. Swelling reported to have begun immediately after injection, 2/19/19. Redness started following morning, 2/20/19 with increasing redness throughout the day. Patient states he had hives night of 2/20/19 but they had resolved before his appointment here 2/21/19. Patient did not have this type of reaction to first GARDASIL received a year ago but had been taking Zyrtec routinely at that time. He has not been taking Zyrtec routinely recently. Mom gave Zyrtec 10mg evening of 2/20/19 and again morning of 2/21/19.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient received GARDASIL 9 vaccine IM right deltoid. Usual complaints of discomfort at time of injection. Waited in office 15 minutes after injection and left office without further complaint or concern. Parent called next afternoon saying patient was complaining of right arm redness, pain and swelling. Swelling reported to have begun immediately after injection, 2/19/19. Redness started following morning, 2/20/19 with increasing redness throughout the day. Patient states he had hives night of 2/20/19 but they had resolved before his appointment here 2/21/19. Patient did not have this type of reaction to first GARDASIL received a year ago but had been taking Zyrtec routinely at that time. He has not been taking Zyrtec routinely recently. Mom gave Zyrtec 10mg evening of 2/20/19 and again morning of 2/21/19.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood lactic acid, Blood pressure immeasurable, Chills, Dyspnoea, Full blood count
Clinical narrative: Chills, SOB, Hypoxemia, generalized tremors, Heart faint and hard to hear, Unable to palpate pulse and O2 sat registers in the 60's, unable to obtain BP. Pt was sent to ER had test and IV and discharge home. Pt was given TORADOL 15 mg, BENADRYL 12.5 mg, SOLU-MEDROL 60mg, NS 0.9 100ML.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypoxia, Lipase, Metabolic function test, Pulse absent, Tremor
Clinical narrative: Chills, SOB, Hypoxemia, generalized tremors, Heart faint and hard to hear, Unable to palpate pulse and O2 sat registers in the 60's, unable to obtain BP. Pt was sent to ER had test and IV and discharge home. Pt was given TORADOL 15 mg, BENADRYL 12.5 mg, SOLU-MEDROL 60mg, NS 0.9 100ML.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Hives noted at 5:45 pm on 1/16/19 on entire body - scattered. Mother gave BENADRYL 1 dose and by evening only a few hives remained. AM on 1/17/19 had hives again mother gave a dose of either CLARITIN or ZYRTEC before patient went to school. In the evening of 1/17/19 mother states "had spots on her arms and stomach that looked like bite marks". Mother gave a dose of BENADRYL at that time. Friday AM 1/18/19 rash/spots were completely gone. Mother stated that patient had redness and swelling at the (R) thigh injection site that lasted through Saturday 1/19/19. Patient had a previously scheduled physical appointment with her PCP on 1/21/19. Immunization reaction was discussed at that time.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (wrong product stored), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007549: US-009507513-1902USA007548: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007544: US-009507513-1902USA007550: US-009507513-1902USA007537.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 5 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1901USA008772: US-009507513-1902USA007537: US-009507513-1902USA007538: US-009507513-1902USA007539: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 16-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007536: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007539: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 19-OCT-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007537: US-009507513-1902USA007539: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 3 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Age: 1.33
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 16 months year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550:
Age: 1.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 23 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1902USA007541:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 06-NOV-2018  the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007541: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550:
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 3 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007541: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 18 years old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error and product administered to patient of inappropriate age), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments:  US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007541: US-009507513-1902USA007543: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1901USA008772: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550:
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 7 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1901USA008772: US-009507513-1902USA007550: US-009507513-1902USA007549: US-009507513-1902USA007548: US-009507513-1902USA007547: US-009507513-1902USA007546.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1901USA008772.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1901USA008772.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received 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 influenza-like symptoms, fever and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter asked should we take the second shot of SHINGRIX vaccine if we are sick with flu like symptoms and running fever.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Influenza like illness, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), injection site swelling and influenza-like symptoms. On an unknown date, the outcome of the cellulitis and injection site swelling were unknown and the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the cellulitis, injection site swelling and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm swelling at injection site, cellulitis and flu like symptoms for 2 weeks. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, fever, chills and headache. On an unknown date, the outcome of the pain, fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain, fever, chills and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a healthcare professional (HCP). The age at vaccination was not reported. The patient experienced soreness, fevers, chills and headaches that lasted about 24 hours. This case has been linked with case US2019GSK030864 reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included endometriosis. On 17th July 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th July 2018 18:00, 5 hrs after receiving SHINGRIX, the patient experienced pain in arm, weakness, tremor, pain, appetite lost and feeling unwell. On an unknown date, the outcome of the pain in arm, weakness, tremor, pain, appetite lost and feeling unwell were recovered/resolved. The reporter considered the pain in arm, weakness, tremor, pain, appetite lost and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. In the early evening, around 6pm, the patient experienced sore in arm where she received the vaccine for several days, felt very weak, shaky, felt sick, lost her appetite and went right to bed. The patient was also shaking once in bed. The following day after receiving the vaccine, the patient still did not have an appetite but was able to walk around during the day. The patient reported these symptoms lasted about 3 to 5 days before the events resolved completely. The reporter did not consent to follow up. For tolerance to the 2nd dose of SHINGRIX refer case US2019025068, reported by same reporter. The suspect vaccine was captured as SHINGRIX vaccine instead of Flu vaccine as per the case description.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vaccination site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included endometriosis. On 17th July 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th July 2018 18:00, 5 hrs after receiving SHINGRIX, the patient experienced pain in arm, weakness, tremor, pain, appetite lost and feeling unwell. On an unknown date, the outcome of the pain in arm, weakness, tremor, pain, appetite lost and feeling unwell were recovered/resolved. The reporter considered the pain in arm, weakness, tremor, pain, appetite lost and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. In the early evening, around 6pm, the patient experienced sore in arm where she received the vaccine for several days, felt very weak, shaky, felt sick, lost her appetite and went right to bed. The patient was also shaking once in bed. The following day after receiving the vaccine, the patient still did not have an appetite but was able to walk around during the day. The patient reported these symptoms lasted about 3 to 5 days before the events resolved completely. The reporter did not consent to follow up. For tolerance to the 2nd dose of SHINGRIX refer case US2019025068, reported by same reporter. The suspect vaccine was captured as SHINGRIX vaccine instead of Flu vaccine as per the case description.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blood sugar increased in a 56-year-old male patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. Concurrent medical conditions included diabetes. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th February 2019, less than a day after receiving SHINGRIX, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved. It was unknown if the reporter considered the blood sugar increased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right deltoid. The pharmacist reported that the patient had trouble to keep his blood sugar under 300 units. The patient followed-up with his physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, weakness, nausea and vomiting. On an unknown date, the outcome of the fever, chills, muscle pain, weakness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the fever, chills, muscle pain, weakness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and experienced fever, chills, achy muscles, weakness, nausea and vomiting. The events resolved after 3 days. Consent to follow up was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, weakness, nausea and vomiting. On an unknown date, the outcome of the fever, chills, muscle pain, weakness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the fever, chills, muscle pain, weakness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and experienced fever, chills, achy muscles, weakness, nausea and vomiting. The events resolved after 3 days. Consent to follow up was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, fever, chills and headache. On an unknown date, the outcome of the pain, fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain, fever, chills and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for her colleague. The age at vaccination was not reported. The patient experienced soreness, fevers, chills and headaches that lasted about 24 hours. This case has been linked with case US2019GSK030864 reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Constipation, Diarrhoea, Dizziness, Haemorrhoids, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included pravastatin sodium (Pravastatin), quinapril, metoprolol succinate (Toprol) and testosterone (Testosterone Injection). On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 1st February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, fever, headache, dizziness, spasms, dry heaves and constipation. On 6th February 2019, the patient experienced hemorrhoids. In February 2019, the patient experienced loose stools. On an unknown date, the outcome of the pain in arm, fever, dizziness, spasms, dry heaves, constipation and hemorrhoids were recovered/resolved and the outcome of the headache and loose stools were unknown. It was unknown if the reporter considered the pain in arm, fever, headache, dizziness, spasms, dry heaves, constipation, hemorrhoids and loose stools to be related to SHINGRIX. Additional details were provided as follows: The patient reported arm soreness for 7 days, fever, dizziness, headaches, back spasms, dry heaves, constipation, loose stools, and a popping of an anal hemorrhoid.  The symptoms had improved at time of report. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity, Pyrexia, Retching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included pravastatin sodium (Pravastatin), quinapril, metoprolol succinate (Toprol) and testosterone (Testosterone Injection). On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 1st February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, fever, headache, dizziness, spasms, dry heaves and constipation. On 6th February 2019, the patient experienced hemorrhoids. In February 2019, the patient experienced loose stools. On an unknown date, the outcome of the pain in arm, fever, dizziness, spasms, dry heaves, constipation and hemorrhoids were recovered/resolved and the outcome of the headache and loose stools were unknown. It was unknown if the reporter considered the pain in arm, fever, headache, dizziness, spasms, dry heaves, constipation, hemorrhoids and loose stools to be related to SHINGRIX. Additional details were provided as follows: The patient reported arm soreness for 7 days, fever, dizziness, headaches, back spasms, dry heaves, constipation, loose stools, and a popping of an anal hemorrhoid.  The symptoms had improved at time of report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the medical doctor for herself. The patient received SHINGRIX in the upper gluteal or hip region rather than in the deltoid. The reporter indicated that the responsible physician and nurse practitioner suggested the alternative injection site due to the patient being petite with little muscle mass in the deltoid region. The patient subsequently experienced marked local reaction with significant swelling, redness and pain which had increased progressively over the past three days of reporting. The patient had been taking ADVIL with little relief of symptoms. Batch number, date of birth and administration facility address were not provided.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced passed out (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a clinic for one of the physicians at the practice. The age at vaccination was not reported. The age group was not reported, but was captured adult as per the patient's profession. Recently from the reporting date, the patient received a SHINGRIX shot and the next day he experienced passing out and has been hospitalized. No further details were available.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Injection site movement impairment, Pyrexia, Walking aid user
Clinical narrative: PER FATHER, SLIGHT FEVER WITHOUT USE OF THERMOMETER BY 7:55PM. BY MORNING OF FEB 21, CHILD WAS LIMITING MOVEMENTS WITH LEGS AND USING SUPPORT TO WALK. BY 11:30AM ON FEB 21, CHILD ABLE TO STAND BY SELF WITHOUT SUPPORT. BY 1:15PM, PER FATHER, CHILD WAS MOVING BETTER AFTER WRM BATH AND SECOND DOSE OF CHILD MOTRIN. CHILD EATING AND PERSONALITY IS NORMAL.PARENT CONFIRMED CHILD LAUGHING IN BACKGROUND WHILE I WAS ON PHONE WITH PARENT. WILL FOLLOW UP WITH PHONE CALL ON FEB 22.ADVISED AT ANY TIME PARENT WAS CONCERNED ABOUT CHILDS HEALTH TO CALL MD OR GO TO ER.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Cellulitis, Chills, Injection site erythema, Injection site pain
Clinical narrative: Patient contacted our office on 2/20/19 in the afternoon the day after immunization. Reported chills, fever, pain at injection site and swelling. Reports that the swelling and redness had increased and moved down her left upper arm to her elbow. Directed to clinic. Dx with cellulitis and given oral antibiotics. Saw her PCP this morning 2/21/19 who assessed cellulitis and placed pneumoccocal vaccine on her current list of allergies. Redness and swelling is improving but still present.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient contacted our office on 2/20/19 in the afternoon the day after immunization. Reported chills, fever, pain at injection site and swelling. Reports that the swelling and redness had increased and moved down her left upper arm to her elbow. Directed to clinic. Dx with cellulitis and given oral antibiotics. Saw her PCP this morning 2/21/19 who assessed cellulitis and placed pneumoccocal vaccine on her current list of allergies. Redness and swelling is improving but still present.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Extreme fatigue, nausea, and dizzy.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Tachycardia
Clinical narrative: Approx. 2-3 hours after receiving vaccine he had tachycardia and chest tightness with deep inhalation. He had soreness at the left arm at site of injection. He took BENADRYL last night under a doctor's direction. He has mild erythema and tenderness at site. Put on prednisone 60mg for 5 days.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chest discomfort, Injection site pain, Tachycardia
Clinical narrative: Approx. 2-3 hours after receiving vaccine he had tachycardia and chest tightness with deep inhalation. He had soreness at the left arm at site of injection. He took BENADRYL last night under a doctor's direction. He has mild erythema and tenderness at site. Put on prednisone 60mg for 5 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: Patient reported getting some bumps on her back a day or so after receiving the Shingles vaccination. She states that she got the same type of reaction upon receiving the first shot in the series and her physician told her to use a warm compress and the bumps went away after several weeks. On this occasion, her physician prescribed valacyclovir 1 gram to be taken 3 times a day for 7 days with a diagnosis of zoster without complications B02.9.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Patient reported getting some bumps on her back a day or so after receiving the Shingles vaccination. She states that she got the same type of reaction upon receiving the first shot in the series and her physician told her to use a warm compress and the bumps went away after several weeks. On this occasion, her physician prescribed valacyclovir 1 gram to be taken 3 times a day for 7 days with a diagnosis of zoster without complications B02.9.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: The night of her Vaccine, she had a seizure that seemed to be from a fever. Then she had 7 more seizures in the next 7 days. As of now she is on medication in case it is epilepsy. Hasn't been confirmed that this is the cause, but the CDC website lists it as a possible side effect.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Headache, Pain, Paraesthesia
Clinical narrative: Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.