chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: interstitial keratitis; Shingles; visual disturbance in left eye due to shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, reported as after injection, the patient suffered a painful blistering rash on the left side of his face, forhead and scalps. As a result of his symptoms, the pt presented to a medical provideder and was diagnosed with shingles, as well as, visual disturbance in left eye due to shingles and interstital keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcomes of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the events of keratitis interstitial and visual disturbance in left eye due to shingles were determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000928: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000862: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA002218: US-009507513-1907USA003025: US-009507513-1907USA003024:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA003025: US-009507513-1907USA003023: US-009507513-1907USA002218:
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: arm weakness; discomfort; This case was reported by a other health professional via call center representative and described the occurrence of weakness of arms in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness of arms and arm discomfort. On an unknown date, the outcome of the weakness of arms and arm discomfort were not recovered/not resolved.   The reporter considered the weakness of arms and arm discomfort to be related to Shingrix.  Additional details were reported as follows: About 8 weeks before the time of reporting, the patient received a dose of Shingrix. The patient experienced constant arm weakness and discomfort. Before the patient go back to receive 2nd dose in the next week, the patient just wanted to inform that, the 1st dose did leave the patient with some long-term arm weakness and discomfort but nothing else. The patient stated that having a physician assistant (PA) as a daughter helped the patient because she encouraged the patient to do less 12 ounce curls and pick up the dumbbells more. The patient took her advice and stated we should see the discomfort and weakness was real and unexpected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash/red dots; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and had rash which broke out on chest.  At the time of reporting, the patient came for 2nd dose and still having red dots on her chest.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Nausea
Clinical narrative: Nausea; Flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of nausea in an unspecified number of adult patient who received Herpes zoster (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 nausea and flu symptoms. On an unknown date, the outcome of the nausea and flu symptoms were unknown.   It was unknown if the reporter considered the nausea and flu symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. A pharmacist reported to the consumer that he had some people report it was so bad and she would not be abled to work for two days. The patients received Shingrix, and experienced nausea and flu symptoms. At the time of report, the consumer was terrified. No further information provided and the call was remotely disconnected prior to more information being captured.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Flu-like symptoms - fever, chills, nausea, headache, weakness, which lasted for about 24 hours. Pain, hotness, hardness and redness at injection site, which lasted for four days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Flu-like symptoms - fever, chills, nausea, headache, weakness, which lasted for about 24 hours. Pain, hotness, hardness and redness at injection site, which lasted for four days.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain 9/10 in arm.  Under/inner arm is swollen, red and hot to touch.  No fever reported.  No visible injection site reaction.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: approximately 4 hours after receiving the vaccine, patient had fatigue, chills, and body aches. Patient had a fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: 3-4 inch in diameter redness and swelling at site; painful to any touch for 10 days, soreness still present after 3 weeks, pain in neck into shoulder, tiredness
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: 3-4 inch in diameter redness and swelling at site; painful to any touch for 10 days, soreness still present after 3 weeks, pain in neck into shoulder, tiredness
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Fatigue, chills, body aches. Patient said arm hurt so badly she was unable to perform normal tasks like taking a shower. Symptoms began approximately 4 hours after vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: Patient reported a numb arm, as well as extreme soreness at injection site.  The patient experience a rash the next day on both arms, resembling chicken pox.  The patient reported the rash and symptoms two days later to the pharmacy and still had the rash at time of report.  He said that the rash was much more prevalent the day immediately following administration.  The patient also experienced mild flu like symptoms such as myalgia and also a dry mouth.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient reported a numb arm, as well as extreme soreness at injection site.  The patient experience a rash the next day on both arms, resembling chicken pox.  The patient reported the rash and symptoms two days later to the pharmacy and still had the rash at time of report.  He said that the rash was much more prevalent the day immediately following administration.  The patient also experienced mild flu like symptoms such as myalgia and also a dry mouth.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported / No AE/PQC; improperly stored dose of PEDVAX HIB was administered to the patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.   On 19-JUN-2019, the patient received an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027328 and expiration date 12-JUL-2021) (dose and route of administration were not reported), for prophylaxis. The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a total time and highest temperature excursion above 47 Fahrenheit degrees (°F)/9 Celsius degrees (°C) (47.4 F) during a timeframe of 1 hour and 30 minutes, which was detected by a data logger. There were no previous temperature excursions. No adverse events reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for the prevention of shingles. On an unknown date, after receiving the vaccination, the patient suffered a painful rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster. The patient did not recover from the event as she continued to suffer the effects of herpes zoster at the time of the report. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms and diagnoses resulted in physical limitations not present prior to using the product and  the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The causality assessment was reported as related. Herpes zoster is considered to be disabling.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA003025: US-009507513-1907USA003024: US-009507513-1907USA003023:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA003024: US-009507513-1907USA003023: US-009507513-1907USA002218:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Product administered at inappropriate site, Pyrexia
Clinical narrative: Fever; chills; Vaccine administered at inappropriate site; vomiting; redness around the site; puffiness around the site; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fever, chills, vomiting, injection site erythema, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the outcome of the fever, chills and vaccine administered at inappropriate site were unknown and the outcome of the vomiting, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, chills, vomiting, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced Fever (102 -103) and chills about 3 hours after the dose that progressed. The patient also experienced Vomiting and redness and puffiness around the site which lasted for 3-4 days. The patient received the dose in the gluteus, which led to vaccine administered at inappropriate site.      Lab Comments: On an unknown date body temperature was noted
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever; chills; Vaccine administered at inappropriate site; vomiting; redness around the site; puffiness around the site; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fever, chills, vomiting, injection site erythema, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the outcome of the fever, chills and vaccine administered at inappropriate site were unknown and the outcome of the vomiting, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, chills, vomiting, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced Fever (102 -103) and chills about 3 hours after the dose that progressed. The patient also experienced Vomiting and redness and puffiness around the site which lasted for 3-4 days. The patient received the dose in the gluteus, which led to vaccine administered at inappropriate site.      Lab Comments: On an unknown date body temperature was noted
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via sales rep and described the occurrence of rash in a adult patient who received Herpes zoster (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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was presented with rash after administration with Shingrix. The reporter did not have patient information at the time of reporting.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Off label use
Clinical narrative: shingles; Off label use; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and off label use. On an unknown date, the outcome of the shingles and off label use were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced internal shingles. The patient's physician ordered a 2nd dose to be administered earlier than recommended, which led to off label use. At the time of reporting, 2nd dose was not administered.
Sex: U
Vaccine: MNQ
Symptoms: Hypersensitivity, Product preparation issue
Clinical narrative: allergic reaction; Inappropriate Reconstitution Technique; inappropriate dose of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA08A, expiry date 31st March 2021) for prophylaxis.   In June 2019, the patient received Menveo. In June 2019, less than a week after receiving Menveo, the patient experienced allergic reaction, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the allergic reaction, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient experienced allergic reaction. No details regarding patient or further details regarding allergic reaction were available. The reporter stated that, the medical assistant was unsure when patient was vaccinated. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: RV1, RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: Diarrhea; Vomiting; Vaccine Failure; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number G7XE3, expiry date 13th February 2020) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 273FR, expiry date 15th February 2020) for prophylaxis.   On 5th December 2018, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 13th February 2019, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 19th June 2019, 196 days after receiving Rotarix lyophilized formulation and 126 days after receiving Rotarix lyophilized formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria hospitalization and GSK medically significant) and vomiting (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and diarrhea rotavirus were unknown and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and vomiting to be related to Rotarix lyophilized formulation and Rotarix lyophilized formulation.  Additional details were provided as follows: The patient developed symptoms but got worse and was sent to the hospital. In June 2019, the patient was admitted and on 23rd June 2019 was discharged. On 24th June 2019, the patient was seen in the office for a post hospital follow-up. heir diarrhea at that time had lessened, but was ongoing. The patient was diagnosed with rotavirus in the hospital The reporter was okay with follow up. This case was linked to case US2019117687, reported by same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: patient received 2nd dose 5/10/19. complained to pharmacy 7/5/19 12:40pm that there is soreness in right arm, where vaccine was given for close to 60 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: 2 days after Shingrix vaccine had a large red rash over injection site. It was very sore. She saw an Hospital ER provider on 7/3/19. Took Vitals - slightly elevated BP - all other vitals normal. The ER drew a circle around rash with marker. She was told to use warm or cold compress, take tylenol or ibuprofen as needed, and to return to ER or primary MD if got worse. As of 7/5/19 the rash is almost gone and the arm is still sore.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Patient fainted for a brief second and appeared to have seizure for a couple seconds. Patient was given benadryl and allowed to rest in store for about 30 minutes.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: on 5/21/19 reports chills with fever to 100.3 po . Next day knee foot ankle and hip pain.  Then reports rash.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: on 5/21/19 reports chills with fever to 100.3 po . Next day knee foot ankle and hip pain.  Then reports rash.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Pt had adverse reaction to pneumo 23 vaccine. Pt returned to our office the next day after receiving vaccine with left arm redness, swelling & pain. Pt treated with antibotics Amoxicillin 500mg x10days, Loratadine 10mg once daily and Ibuprofen 600mg prn pain. Pt returned 1 week later on 07/05/19 Dr. reassessed patient-cellulitis resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Rash
Clinical narrative: Patient described a rash beneath the breasts that started the afternoon of receiving the vaccine and excruciating joint pain.  The patient said the pain was so bad that she was bed-ridden the next day.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hypogeusia, Hyposmia, Injection site pain, Lethargy
Clinical narrative: Initially severe shivering initiated suddenly and without prior symptoms about 12 hours after injection; severe episode lasting about 1.5 hours then tapered off slowly; general malaise, lethargy and difficulty focusing; area around injection site very sore and touch sensitive; slight swelling and tingling of hand on injection (left) arm. Next morning (24 hours after injection) I noticed a marked decrease in smell and taste senses but that resolved over the subsequent day.  All symptoms resolved within 48 hours after injection;
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Paraesthesia, Peripheral swelling, Vision blurred
Clinical narrative: Initially severe shivering initiated suddenly and without prior symptoms about 12 hours after injection; severe episode lasting about 1.5 hours then tapered off slowly; general malaise, lethargy and difficulty focusing; area around injection site very sore and touch sensitive; slight swelling and tingling of hand on injection (left) arm. Next morning (24 hours after injection) I noticed a marked decrease in smell and taste senses but that resolved over the subsequent day.  All symptoms resolved within 48 hours after injection;
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Blood thyroid stimulating hormone increased, Fatigue, Thirst
Clinical narrative: The day after getting the vaccine felt extreme fatigue that lasted 2 weeks.  No fever but altered activity level and felt thirsty all the time.  Had mono in the past and felt like she was having a reactivation of mono.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza
Clinical narrative: Pt said the day after the shot he had mild flu symptoms, but the day after that he started feeling very tired, and had significant tiredness for over a month after getting the shot.  He is unsure if he wants to get the 2nd shot in the same series
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: redness, swelling, warm to the touch.  Starting 24 hours after injection and rash is approx. 2 inches below injection site
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were administered improperly stored RECOMBIVAX HB; No adverse effects reported; Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided.   On unknown dates, the patients received improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R012001 and expiration date 06-NOV-2020) (dose and route of administration were not reported), for prophylaxis. The vaccines were exposed to a temperature excursion of 18.6 Celsius degrees (°C) (9 °C to 25 °C) during a time frame of 96 minutes which was detected by a digital data logger. There was a previous temperature excursion of 9 °C to 25 °C during 167 minutes. No adverse effects were reported.     This report was a non-valid case as there was no information about the patients' identification.  As of 03-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effects reported; 0.5mL of an adult dose of Vaqta was administered to a 17 year old patient as the patient's adolescent dose; This spontaneous report was received from a nurse, referring to a 17 year old patient, of unspecified gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug allergies or reactions were not reported.  On 12-APR-2019, the patient was vaccinated with 0.5 milliliters of an adult dose of hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly, lot # R030120  with expiration date 15-NOV-2019, for prophylaxis (incorrect dose administered), the anatomical site of injection and the dose number were not provided. There were no adverse events reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Feeling abnormal
Clinical narrative: feels awful; Negative reaction; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced feels awful and adverse event. On an unknown date, the outcome of the feels awful and adverse event were unknown.   It was unknown if the reporter considered the feels awful and adverse event to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose of Shingrix and felt awful and had negative reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: muscle/joint ache; felt like crud/crummy; joint aches; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain, feeling unwell and joint pain. On an unknown date, the outcome of the muscle pain, feeling unwell and joint pain were recovered/resolved.   It was unknown if the reporter considered the muscle pain, feeling unwell and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the patient. The age at vaccination was not reported. The patient said she felt like crud and crummy after receiving Shingrix She received 1st dose in February or March of 2019. The 1st dose she cannot remember if it was right deltoid or left deltoid. She states that she did experience muscle and joint aches with the Shingrix as well which resolved. She did not say if she experienced chills or arm pain. The reporter consented to follow up. For the tolerances of 2nd dose, refer case US2019116804.
Sex: F
Vaccine: MENB
Symptoms: Meningitis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown.   It was unknown if the reporter considered the vaccination failure and meningitis to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and still got meningitis. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Nausea, Pain in extremity
Clinical narrative: Burning foot; pain in her arm; Nausea; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date). Concurrent medical conditions included herpes virus infection.   On 10th June 2019, the patient received the 2nd dose of Shingrix. On 11th June 2019, 1 days after receiving Shingrix, the patient experienced nausea. On 12th June 2019, the patient experienced headache. In June 2019, the patient experienced pain in arm and burning foot. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, nausea, headache and burning foot were recovered/resolved.   It was unknown if the reporter considered the pain in arm, nausea, headache and burning foot to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in her arm, but not as much, but also felt very nauseous and had a terrible headache. The symptoms lasted about 4 days before resolving. The patient had the burning sensation in her feet. The patient state that it was not as bad and did not last as long as after the 1st dose. The burning was sporadic and tended to happen after exercising or walking around a lot. The patient did not consent to follow up. This case has been linked with US2019115024, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Phototherapy, Rash, Rash pruritic, Skin burning sensation
Clinical narrative: Rash on scalp, arms, back, and legs; Itching; Burning; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, itchy rash and burning sensation skin. The patient was treated with non-drug therapy (Phototherapy). On an unknown date, the outcome of the rash, itchy rash and burning sensation skin were recovered/resolved.   It was unknown if the reporter considered the rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional information received were as follows: The patient experienced horrible rash that itched and burned. The rash was on her scalp, arms, back, and legs, which had got thicker over time and was spreading. The rash alternates between starting to get worse, then getting better, then worse again. On 28th February 2019, 5th March 2019, 7th March 2019, 9th March 2019, 13th March 2019, 21st March 2019, 26th March 2019, 29th March 2019, 2nd April 2019, 4th April 2019, 27th May 2019, 20th May 2019, 3rd June 2019, 4th June 2019, 7th June 2019 and 10th June 2019, the patient had received phototherapy treatments to treat the rash. The reporter was unable to provide any additional details. The reporter did not know what dose in the 2 dose series that the patient received, etc.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Pruritus
Clinical narrative: itchy blister; watery blister; blister broke open; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles Vaccine (received 1 year ago).   On 21st June 2019, the patient received the 1st dose of Shingrix. On 24th June 2019, 3 days after receiving Shingrix, the patient experienced pruritus, blister and blister rupture. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the blister and blister rupture were unknown.   It was unknown if the reporter considered the pruritus, blister and blister rupture to be related to Shingrix.  Additional details were provided as follows:  The patient had the previous shingles shot years ago and she has a history of shingles. On 21st June 2019, the patient received the 1st dose of Shingrix in left arm. On 24th June 2019, she noticed two blisters approximately 6 inches below the injection site on her left arm. The blisters were itchy and watery. The blisters were worse and bigger and one has broke open.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles on face, specifically on eye lid, cheek and neck; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A few months after receiving 1st dose of Shingrix, the patient developed shingles on her face, specifically on her eye lid, cheek and neck. The doctor daignosed it as shingles. No further information was provided.
Age: 25.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Product administered to patient of inappropriate age, Therapy non-responder
Clinical narrative: Therapy non-responder; Overdose; Overdose; Overdose; underdose; Adult product administered to child; Adult product administered to child; Adult product administered to child; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 25-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult and the 2nd dose of Engerix B adult. On 7th December 1994, the patient received the 3rd dose of Engerix B adult. On 24th June 2019, the patient received the 4th dose of Engerix B pediatric (intramuscular) .5 ml. On an unknown date, unknown after receiving Engerix B adult, Engerix B adult and Engerix B adult and not applicable after receiving Engerix B pediatric, the patient experienced therapy non-responder, overdose, overdose, overdose, underdose, adult product administered to child, adult product administered to child, adult product administered to child and adult use of a child product. On an unknown date, the outcome of the therapy non-responder, overdose, overdose, overdose, underdose, adult product administered to child, adult product administered to child, adult product administered to child and adult use of a child product were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B adult, Engerix B adult and Engerix B adult.  Additional details were provided as follows: The patient received Engerix B pediatric in left deltoid. She stated already had received three doses of the Engerix B adult, but after titers were obtained, the patient was found to be nonimmune and thus received the 4th dose of Engerix B pediatric, which led to underdose and Adult use of a child product. The patient was given a Engerix B pediatric vaccine instead of the Engerix B adult (1 ml) vaccine, which led to underdose and adult use of a child product.  The reporter gave consent to follow up.      Lab Comments: after titers were obtained, the patient was found to be nonimmune
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Rash vesicular
Clinical narrative: shingles; Painful rash; burning; Vesicular rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix. On 23rd June 2019, 1 days after receiving Shingrix, the patient experienced shingles, painful rash, burning sensation and vesicular rash. The patient was treated with gabapentin and antivirals nos. On an unknown date, the outcome of the shingles was unknown and the outcome of the painful rash, burning sensation and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, painful rash, burning sensation and vesicular rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced a vesicular rash extending from 1.5 inches up their bicep and all the way down to the palm of their hand. The rash was painful and burning, and the patient was diagnosed with shingles by the reporter. At the times of report, all symptoms were present. The lot number and expiration dates were not available.