chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: Felt bad; General malaise; fever; headache; joint ache; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 days after receiving Shingrix, the patient experienced feeling bad, malaise, fever, headache, joint pain and nausea. On an unknown date, the outcome of the feeling bad, malaise, fever, headache, joint pain and nausea were recovered/resolved.   The reporter considered the feeling bad, malaise, fever, headache, joint pain and nausea to be probably related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 10 days later he felt bad. He experienced general malaise with fever, headache, joint ache and nausea. His doctors said it was probably from the Shingrix vaccine. All his symptoms resolved after two weeks.The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field of database (recovered) and the outcome reported in the source document (recovered with sequel).
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Felt bad; General malaise; fever; headache; joint ache; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 days after receiving Shingrix, the patient experienced feeling bad, malaise, fever, headache, joint pain and nausea. On an unknown date, the outcome of the feeling bad, malaise, fever, headache, joint pain and nausea were recovered/resolved.   The reporter considered the feeling bad, malaise, fever, headache, joint pain and nausea to be probably related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 10 days later he felt bad. He experienced general malaise with fever, headache, joint ache and nausea. His doctors said it was probably from the Shingrix vaccine. All his symptoms resolved after two weeks.The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field of database (recovered) and the outcome reported in the source document (recovered with sequel).
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoacusis, Pallor, Visual impairment
Clinical narrative: Patient felt light headed after receiving her shot.  She was pale .she stated she couldn't see or hear. she felt faint and sat down. she was given fluids and nutrients and regained her composure. Patient did not need further medical treatment. She was fine after about 10 minutes. Patient was ambulatory within 10 minutes
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Erythema, Injection site erythema, Injection site pruritus, Paraesthesia
Clinical narrative: Individual who is a teacher complained of arm tingling, redness from injection site to fingers and itchy. Person began experiencing throat/chest tightness. Epinephrine injection administered by the school nurse and then transported via EMS.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Throat tightness
Clinical narrative: Individual who is a teacher complained of arm tingling, redness from injection site to fingers and itchy. Person began experiencing throat/chest tightness. Epinephrine injection administered by the school nurse and then transported via EMS.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Evening after the vaccination patient was sore and red. Next morning she had larger rash, itching , redness and swelling at the injection site.  Next day today, she is itching a lot, swollen and rash has expanded to 5 x 7 inches.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; a patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. There was no information about the patient's concurrent conditions, drug reactions/allergies and medical history provided.  On 30-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S011951, expiration date was 16-APR-2019, but upon internal validation established as 16-APR-2021) (dose details and route of administration were not reported)for prophylaxis. The sterile diluent(lot #S015772, expiration date was 15-FEB-2022) used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. The storage temperatures of the varicella virus vaccine live (oka/merck) (VARIVAX) was -12.3 degree Celsius for 6.05 hours. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse effects noted.   This is one of the seven reports received form the same reporter.; Sender's Comments:  US-009507513-1910USA007375: US-009507513-1910USA007348: US-009507513-1910USA007200: US-009507513-1910USA007189: US-009507513-1910USA007211: US-009507513-1910USA006992:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, drug allergies/reactions concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (one dose, lot # S009757, expiration date 27-SEP-2020, strength, frequency and route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature 32.5 Fahrenheit for 8 hours. There was no previous temperature excursion and the call was because of a data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On an unknown date the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S007075, expiration date 06-SEP-2020, route of administration, and strength were not provided) for prophylaxis. The storage temperature was reported as 32.5 degrees Fahrenheit (F) for 8 hours. There was no previous temperature excursion. Digital data logger was involved.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were provided; inadvertently administered one dose of expired PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 23-OCT-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # R011216, expiration date 15-OCT-2019, route and strength were not reported) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Herpes Zoster/painful blistering rash; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful blistering rash. The pt presented to his medical provider and was diagnosed with herpes zoster. Despite receiving treatment, the pt continued suffering from herpes zoster. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt 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 pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received a dose of improperly VARIVAX; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical historyand concurrent condition were not provided.  On 24-SEP-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023502, expiration date 16-AUG-2010; dose, strength and route were unknown) for prophylaxis, which was reconstituted with properly stored sterile diluent. The vaccine was exposed to temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (21.7 degrees Fahrenheit) for 360 minutes (incorrect product storage). There was no previous temperature excursion. The data logger was involved. No adverse effects were reported.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse reported that the third dose ofROTATEQ was administered to an unspecified patient at 8 months and 12 days old on unspecified date; No adverse affects reported; This spontaneous report was received from a nurse referring to an 8 month and 12 days old patient of unknown gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On an unknown date the patient was vaccinated with the third dose rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (dose was not provided, lot #S000961, expiration date 19-OCT-2020) by oral for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; Patient received a dose of Vaqta on 05/003/2019 and on 10/24/2019; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not disclosed.  On 03-MAY-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot number and expiration date were unknown by the reporter); afterwards, on 24-OCT-2019, the patient received another dose of hepatitis a vaccine, inactivated (VAQTA) (lot number S007770, expiration date 24-JUL-2020). Both doses were received as prophylaxis (strength, route of administration, anatomical injection site and indication were not reported for either dose) (inappropriate schedule of product administration). No adverse effects were reported.
Age: 1.58
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Incorrect product storage; This spontaneous report has been received from a medical assistant, concerning a 19-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 19-SEP-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RII) lot number R008029, expiration date 18-MAR-2020, for prophylaxis (strength, dose, route of administration, and anatomical location of vaccination were not reported)    The sterile diluent used to reconstitute the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RII) was stored properly. No adverse effects were reported.   The vaccine was stored at a temperature range of above 47° Fahrenheit (F) (52°F) for the time frame of 10 hours.   There was no previous temperature excursion and the call was because of a data logger.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of improperly stored MMR II was inadvertently administered to one patient; This spontaneous report was received from a medical assistant, referring to a 4 year old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported. Concomitant therapies included sterile diluent used to reconstitute the vaccine, it was noted that the diluent was properly stored.  On 03-OCT-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis, lot number R028003 expiration date 01-OCT-2020 (strength, frequency, route of administration and anatomical injection site were not provided).  It was reported that this vaccine had been on a temperature excursion and was stored above 47 °F (52°F) during 10 hours; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One dose of improperly stored MMR II was inadvertently adminsitered to the one patient on 10/16/2019.; This spontaneous report was received from a medical assistant referring to 12-month-old patient. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 16-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot #R028003 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 01-OCT-2020) (strength, dose, frequency and route of administration, were not provided).  The temperature of storage and time frame of the excursion were above 47°F (Fahrenheit) and 10 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Corneal scar, Depression, Herpes zoster, Impaired quality of life, Neuralgia
Clinical narrative: nerve pain; painful outbreak of shingles on his back, upper extremities; shingles of eyes; scarring of the cornea; other vision problems; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided.On or around 02-MAR-2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose detail, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).As a result of receiving zoster vaccine live(ZOSTAVAX), pt suffered scarring of the cornea and other vision problems on or about June 2016. In December 2016, pt suffered a painful outbreak of shingles on his back, upper extremities and eyes. Pt had suffered numerous outbreaks since that date which had created extreme nerve pain, depression and had negatively affected his life. All of these issues were caused by zoster vaccine live(ZOSTAVAX).As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and had suffered economic losses due to his inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries, emotional injuries and loss of consortium. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX),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 zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The events ophthalmic herpes zoster, herpes zoster, neuralgia, visual impairment and corneal scar were considered to be disability. Upon internal review, ophthalmic herpes zoster was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Visual impairment
Clinical narrative: nerve pain; painful outbreak of shingles on his back, upper extremities; shingles of eyes; scarring of the cornea; other vision problems; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided.On or around 02-MAR-2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose detail, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).As a result of receiving zoster vaccine live(ZOSTAVAX), pt suffered scarring of the cornea and other vision problems on or about June 2016. In December 2016, pt suffered a painful outbreak of shingles on his back, upper extremities and eyes. Pt had suffered numerous outbreaks since that date which had created extreme nerve pain, depression and had negatively affected his life. All of these issues were caused by zoster vaccine live(ZOSTAVAX).As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and had suffered economic losses due to his inability to work. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries, emotional injuries and loss of consortium. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX),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 zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The events ophthalmic herpes zoster, herpes zoster, neuralgia, visual impairment and corneal scar were considered to be disability. Upon internal review, ophthalmic herpes zoster was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of product administration, Lymphadenopathy
Clinical narrative: experienced superclavicular lymph adonopathy; Route of administration: subcutaneously; This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) subcutaneously for prophylaxis (dose, anatomical injection site, lot number and expiration date were not reported) (incorrect route of product administration).   On an unknown date, the patient experienced "superclavicular lymph adonopathy" (lymphadenopathy) after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was unknown by reporter if the patient sought for medical attention, if she received any treatment or if any diagnostic laboratories or studies were performed.  At the time of the report, the outcome of the event and the causality assessment between lymphadenopathy and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; an improperly stored dose of ROTATEQ was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 01-NOV-2019, an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, with lot # R033255 and expiation date on 26-JUN-2020,  for prophylaxis (dose and dose number were not reported) was administered to a patient (product storage error).  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion of 50 degrees Fahrenheit (F)  for 2 hours an 20 minutes. There was previous temperature excursion of 50 degrees F for 30 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported.; an expired dose of VAQTA was administered today; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications was not provided.  It was reported that on 01-NOV-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose number, route of administration and anatomical location of vaccination were not provided; lot number R002487 has been verified to be valid; expiration date 21-APR-2019), that was expired (expired product administered). There were no previous excursions reported.  No adverse effect was reported.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Autoimmune disorder, Vaccination complication
Clinical narrative: vaccine-induced autoimmunity (autoimmune illness); Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS number US-009507513-1806USA003582) from a lawyer who provided plaintiff fact sheet concerning a elderly female patient(pt) of unknown age. The pt was a non-smoker. Pt reported that she had chicken pox in 1947 when she was 7 years old. The pt never received the chickenpox vaccine. On 02-DEC-2018, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as "phenomena", manufacturer unknown) (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the pt experienced vaccine-induced autoimmunity (autoimmune illness). The outcome of autoimmune disorder was unknown. The reporter considered autoimmune disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, autoimmune disorder was determined to be medically significant.; Sender's Comments:  US-009507513-1806USA003582:
Sex: U
Vaccine: PPV, UNK, VARZOS
Symptoms: Labelled drug-drug interaction medication error, Lymphadenopathy, Pain in extremity, Rash, Rash vesicular
Clinical narrative: glands in my neck swelled up; rash with blisters; pneumonia and  flu shot in my right arm; both arms were sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and PNEUMONIA SHOT for prophylaxis.   On an unknown date, the patient received Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA SHOT. On an unknown date, 1 day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm, swollen glands, blistery rash and labeled drug-drug interaction medication error. The patient was treated with hydrogen peroxide and neosporin (nos) (Neosporin). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swollen glands and labeled drug-drug interaction medication error were unknown and the outcome of the blistery rash was recovering/resolving.   It was unknown if the reporter considered the pain in arm, swollen glands and blistery rash to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. The patient received dose of Shingrix in the left arm and dose of Pneumonia and flu shot in the right arm. Next day after vaccination, the patient's both arms were sore but the next day were back to normal. About a week later the glands in the neck swollen and developed a rash with blisters on the right side of the neck. As the patient received Pneumonia and Flu vaccine on the right arm, which led to labeled drug-drug interaction medication error. The patient received hydrogen peroxide and neosporin as a treatment medication. The reporter stated that, the blisters have gone down and the rash was getting better. The patient asked if this reaction to or a side effect from the shingles shot and If so, was this treatment appropriate or should some other action be taken.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever; chills; aches; sick; This case was reported by a physician via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced fever, chills, pain and sickness. In October 2019, the outcome of the fever, chills, pain and sickness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain and sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced fever, chills, aches, called in sick to work and required bedrest. All above events resolved after 48 hours. The patient's wife claimed that the patient would self report to VAERS and was happy to speak to someone from GlaxoSmithKline safety.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and flu vaccine with an associated reaction of pain in extremity (received on an unknown date, refer case US2019AMR197055).   On 5th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On 7th August 2019, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. A day after vaccination the patient experienced pain in her left arm that lasted for approximately 1 day. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Menveo lyophilized powder was reconstituted with diluent other than one provided and administered, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Caller did not have patient information, nor lot or expiration date at time of call.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area was painful; Area was swollen; Area was warm to touch; Redness at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Four to five months before the time of reporting, the patient received a dose of Shingrix on the right arm. There was some redness at the site of injection following administration.   The following day the area was painful, swollen and warm to the touch.  It was lasted approximately 2 weeks before resolving. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Laryngitis, Myalgia, Pyrexia
Clinical narrative: laryngitis; fever; myalgia; fatigue; This case was reported by a physician via call center representative and described the occurrence of laryngitis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced laryngitis, fever, myalgia and fatigue. On an unknown date, the outcome of the laryngitis, fever, myalgia and fatigue were unknown.   It was unknown if the reporter considered the laryngitis, fever, myalgia and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix at the pharmacy. In 2019, the patient experienced laryngitis, fever, myalagia and fatigue. Additional information not provided.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Loss of consciousness
Clinical narrative: aching in her joints real bad; headache; Then at 5am on the 19Oct2019 she passed out; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case is linked to cases 2019SA297783 and 2019SA297790 (same reporter).  This case involves a 50 years old female patient who experienced aching in her joints real bad (arthralgia), then at 5am on the 19oct2019 she passed out (loss of consciousness) and headache (headache), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's family history included Type 1 diabetes mellitus (but her daughter was just diagnosed with Type 1 DM). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) was not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm.  On 19-Oct-2019 at 05:00, 1 day 5 hours after the vaccination the patient experienced passed out (loss of consciousness). This event was assessed as medically significant.  On an unknown date, following the vaccination the patient experienced aching in her joints real bad (arthralgia) and headache (headache). Both events was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was joint pain, passed out and headache.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case involves a 50 years old female patient who experienced joint pain, passed out and headache after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed
Age: 0.17
Sex: M
Vaccine: DTAPIPV, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: N/A Not adverse reactions
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Magnetic resonance imaging, Middle insomnia
Clinical narrative: Patient went to get her annual mandatory Flu Shot. She states that the RN giving her the Flu shot gave it high on the right shoulder area. The RN stated at the time to patient that she had difficulty injection the immunization from the pre-filled syringe. Patient has had pain and   loss of FROM with the right shoulder since receiving the Flu Shot. She has taken Tylenol and OTC NSAIDS with no relief. she has had pain at night waking her from sleep.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: The evening of flu shot my neck began feeling stiff and generally not feeling well, I took Tylenol Cold and Flu.  The stiffness increased in the following days.  I took over-the-counter meds:  Aleve, Motrin, Tylenol extra strength, hoping for a relief.  The neck stiffness interferes with sleep because of the discomfort.  The over-the-counter meds help some.  I s
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Redness, edema and itching at the injection site.  The employee took Benadryl and all symptoms resolved.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash papular
Clinical narrative: Patient c/o generalized  itching . Assessment revealed localized swelling in R arm (area of injection) and redness. Red bumps on extremities and back along face and neck. No dyspnea/LOC/or numbness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Ran fever of 102 degrees and had body aches and pains the next day after being vaccinated.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Feeling hot, Flushing, Injection site urticaria, Urticaria
Clinical narrative: Patient experienced red hot face, hives at injection sites and on chest and shoulder.   She went to urgent care and states she was treated with benadryl injection, cortisone shot and given rx for oral prednisone and loratidine.  She went to work the next morning but is stating that she is feeling flushed. She is going to contact her PCP now.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Local reaction, Pain in extremity, Ultrasound scan normal
Clinical narrative: He received his influenza vaccine by a liaison in his area. A couple of days later, he started noticing soreness in his arm and a small lesion, so he went to the Emergency Department on October 27. An ultrasound was done, which was negative. They felt that this was just a local reaction and did not rise to the level of cellulitis. He notes that it continues to be sore in the deltoid, but has also spread up into the shoulder a little bit. He has never had a significant reaction to influenza vaccine in the past.   Examination of the left deltoid reveals a small 1 millimeter erythematous open wound with no obvious signs of infection. He has mild tenderness in the deltoid. There is no palpable evidence of a deeper wound or an abscess. He has full range of motion of his shoulder
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Wound
Clinical narrative: He received his influenza vaccine by a liaison in his area. A couple of days later, he started noticing soreness in his arm and a small lesion, so he went to the Emergency Department on October 27. An ultrasound was done, which was negative. They felt that this was just a local reaction and did not rise to the level of cellulitis. He notes that it continues to be sore in the deltoid, but has also spread up into the shoulder a little bit. He has never had a significant reaction to influenza vaccine in the past.   Examination of the left deltoid reveals a small 1 millimeter erythematous open wound with no obvious signs of infection. He has mild tenderness in the deltoid. There is no palpable evidence of a deeper wound or an abscess. He has full range of motion of his shoulder
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublock given to 9yr old no treatment required per Clinic. Do not repeat.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Arm hurt badly / couldn't sleep on that arm but could use it for other things; This case was reported by a consumer and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix and he believed that it was administered properly into the his left deltoid. The patient was complained that arm hurt badly for 2 weeks and patient couldn't sleep on that arm but could use it for other things The patient had flu vaccine 2 weeks later in other arm.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Injection site swelling
Clinical narrative: Fever of 100-102; Hot area at injection site; Swollen area at injection site; Headache; Body aches; Chills; Fatigue; Pulse of over 200; This case was reported by a consumer and described the occurrence of fever 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 fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high. On an unknown date, the outcome of the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high were recovered/resolved.   It was unknown if the reporter considered the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever of 100 to 102 degree F for more than 3 days. The patient experienced hot, swollen area that kept getting larger as days by at injection site for 3 days. The patient experienced headache, body aches, chills, fatigue for more than 3 days. The patient experienced pulse of over 200. The reporter spoke with pharmacist twice about side effects and he said it was fine but to report to manufacturer.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 100 to 102 degree F and pulse was over 200.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever of 100-102; Hot area at injection site; Swollen area at injection site; Headache; Body aches; Chills; Fatigue; Pulse of over 200; This case was reported by a consumer and described the occurrence of fever 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 fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high. On an unknown date, the outcome of the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high were recovered/resolved.   It was unknown if the reporter considered the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever of 100 to 102 degree F for more than 3 days. The patient experienced hot, swollen area that kept getting larger as days by at injection site for 3 days. The patient experienced headache, body aches, chills, fatigue for more than 3 days. The patient experienced pulse of over 200. The reporter spoke with pharmacist twice about side effects and he said it was fine but to report to manufacturer.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 100 to 102 degree F and pulse was over 200.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Headache; Bad sweats; This case was reported by a consumer and described the occurrence of headache in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression and anxiety. Concomitant products included fluvoxamine maleate (Luvox).   On 28th October 2019, the patient received Shingrix. On 28th October 2019, less than a day after receiving Shingrix, the patient experienced headache and sweating. On an unknown date, the outcome of the headache and sweating were not recovered/not resolved.   It was unknown if the reporter considered the headache and sweating to be related to Shingrix.  Additional details were provided as follows: The patient was on 150 Luvox for depression and anxiety an the shot did not go with Luvox so she had to win off Luvox. The patient experienced headaches and was sweating terrible. The reporter said that they had nothing to stop the side effects.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the health department nurse. It was reported that, in October 2019, the patient was seen by her primary health physician and was diagnosed and treated for shingles. The reporter consented to follow up. The reporter did not have the physician name or contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash; Blister; This case was reported by a nurse via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and blister. On an unknown date, the outcome of the rash and blister were unknown.   It was unknown if the reporter considered the rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 71 or 72 years. The patient experienced blisters and a rash after receiving the 1st dose of Shingrix. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Influenza like illness, Pyrexia, Swelling
Clinical narrative: Within a few hours of receiving vaccine, child had a small area of localized redness & swelling. Over the next 2 days, he had increasing redness & swelling. 10/31 he had marked increase in redness & swelling - annular 10cm & was seen at a minor Er. Child had been on amoxicillin for an URI with cough. ER left him on amoxicillin. I saw patient the next day and opted to cover possible cellulitis with cephalexin. Area was quite red but was not particularly tender to touch & child was not limping. He did have some fever & flu like symptoms but I did not test him for flu. Child improved over the next days & a phone call to mom on 11/4/19 reported almost complete resolution of erythema. Mom denied that child ever had a noteable scratch in the area of the injection. She did not feel child fought the injection or had significant bruising at the time of the injection. Child has had 3 previous flu shots on 10/17, 1/18,10/18 without any significant reaction. Those vaccines were all fluzone quadirvalent but were the 0.25 dose. (This was the 0.5ml dose). I am not sure whether this was cellulitis or a severe local reaction but thought it should be reported since this was the first year to give children under 3 the higher dose.