chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Full blood count normal, Joint stiffness, Joint swelling, Metabolic function test normal
Clinical narrative: Pt reported mild stiffness and swelling in finger joints after first MMR; states symptoms worsened after second MMR on 2/6/2020. Reports swelling, stiffness and pain in finger joints bilaterally since receiving MMR vaccines in January and February 2020. Symptoms have persisted for over 3 months.
Age: 52.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Red blood cell sedimentation rate normal, Thyroid function test normal
Clinical narrative: Pt reported mild stiffness and swelling in finger joints after first MMR; states symptoms worsened after second MMR on 2/6/2020. Reports swelling, stiffness and pain in finger joints bilaterally since receiving MMR vaccines in January and February 2020. Symptoms have persisted for over 3 months.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SEVERE SWELLING, REDNESS AND PAIN TO INJECTION SITE. PT WENT TO ER AND WAS TREATED WITH NAPROXEN AND TYLENOL. F/U AT THIS CLINIC ALSO ORDERED BETAMETHASONE CREAM AND INSTURCTED TO USE ALTERNATING HOT AND COLD COMPRESSES.
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood parathyroid hormone normal, Blood thyroid stimulating hormone normal, Dysphonia, Feeling of body temperature change, Full blood count normal
Clinical narrative: Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Metabolic function test normal, Nausea, Pruritus
Clinical narrative: Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free normal
Clinical narrative: Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphagia, Dysphonia, Dyspnoea, Headache
Clinical narrative: Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Urticaria
Clinical narrative: "Welts, mild rash and itching at site, lasted 3 days"
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Grip strength decreased, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Starting about 6 pm on 05-22-2020, the client had pain in the left arm starting at the injection site and moving down the arm to his fingers.  He was unable to close his left hand and had no strength in his grip.   There was pain along with numbness and fire, especially to the middle finger on the left hand.  On 05-22-2020, the left hand was swollen, with the rest of the problems continuing.  There was a 2 1/2 inch circle of redness at the injection site.  Client was taking ibuprofen.  As of 05-26-2020, the client is doing much better, but the numbness/tingling continues in the middle finger of the left hand.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Starting about 6 pm on 05-22-2020, the client had pain in the left arm starting at the injection site and moving down the arm to his fingers.  He was unable to close his left hand and had no strength in his grip.   There was pain along with numbness and fire, especially to the middle finger on the left hand.  On 05-22-2020, the left hand was swollen, with the rest of the problems continuing.  There was a 2 1/2 inch circle of redness at the injection site.  Client was taking ibuprofen.  As of 05-26-2020, the client is doing much better, but the numbness/tingling continues in the middle finger of the left hand.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Screaming
Clinical narrative: Mom called this afternoon concerned about screaming ongoing for 1.5 hours. Symptoms not consistent with intussusception.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Screaming x 2+ hours after waking up from nap.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Bladder disorder, Body temperature increased, Chills, Culture urine, Disturbance in attention
Clinical narrative: NOTE - I do not know which Rabies vac was used - it's not on my paperwork -   While one in a billion chance of obtaining rabies from bat spit out of the air when near a roosting site, my irrational mind went to the hospital when I awoke with what felt like flu symptoms in my arms and legs and I started immediate rabies treatment. 36 hours later I felt a sensation in my bladder that instead I may actually be having a UTI which would explain the odd arm/leg flu type chills I was having along with a very hard issue concentrating. I did have a UTI without bladder feeling before but it hit the kidney first with massive pain and while there was no pain this time, the aftermath felt familiar. I had also not slept very well for 60 hours.  Regardless, I started rabies treatment with the 2 shots in the legs of immunoglobulin and first dose of rabies vac in the arm. Type is only shown as purified chick embry cell (5/21/2020). I was also test for covid-19 the same morning as initial symptoms but came back negative.  After receiving my first pass at this vaccine, I woke up after a restless sleep the next morning feeling as if my skin was on fire. That lasted 20-30 minutes and subsided. Later that evening  is when I felt my bladder feeling weird and a home test shows elevated leukocytes so I went the next day to the local clinic to be tested. Initial quick test was negative but all my symptoms fit. I had no cough and temp has never gone over 100.1 and hovers around 98.9 and 99.1 - My baseline is 97.9. I've had on and off feeling of weird tension in my arms/legs but figure it was the shots themselves. By the evening, it was gone and I felt great.  I started Macrobid while awaiting a 3 day longer culture grow tests on my possible UTI and immediately started feeling better.  Finally started sleeping again. Energy and mental clarity returned. Went for my next booster of rabies on 5/24/2020 in the arm at the same hospital. Within 30 minutes I felt the whole upper body skin burning sensation again but not as bad. The whole day I felt great.  Appetite which was non-existent the first 3 days returned finally too.   Today (5-26) I awoke feeling a little shaky again, arms and legs do feel off/strange - but no pins/needles in feet/hands or any other symptoms - the sensations comes and goes. As the day goes on it seems to slowly resolve.  Is this normal behavior of the vaccine? Temp is 99.1. I feel fine otherwise.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Feeling abnormal, Influenza, Muscle tightness, Nervousness, Pain
Clinical narrative: NOTE - I do not know which Rabies vac was used - it's not on my paperwork -   While one in a billion chance of obtaining rabies from bat spit out of the air when near a roosting site, my irrational mind went to the hospital when I awoke with what felt like flu symptoms in my arms and legs and I started immediate rabies treatment. 36 hours later I felt a sensation in my bladder that instead I may actually be having a UTI which would explain the odd arm/leg flu type chills I was having along with a very hard issue concentrating. I did have a UTI without bladder feeling before but it hit the kidney first with massive pain and while there was no pain this time, the aftermath felt familiar. I had also not slept very well for 60 hours.  Regardless, I started rabies treatment with the 2 shots in the legs of immunoglobulin and first dose of rabies vac in the arm. Type is only shown as purified chick embry cell (5/21/2020). I was also test for covid-19 the same morning as initial symptoms but came back negative.  After receiving my first pass at this vaccine, I woke up after a restless sleep the next morning feeling as if my skin was on fire. That lasted 20-30 minutes and subsided. Later that evening  is when I felt my bladder feeling weird and a home test shows elevated leukocytes so I went the next day to the local clinic to be tested. Initial quick test was negative but all my symptoms fit. I had no cough and temp has never gone over 100.1 and hovers around 98.9 and 99.1 - My baseline is 97.9. I've had on and off feeling of weird tension in my arms/legs but figure it was the shots themselves. By the evening, it was gone and I felt great.  I started Macrobid while awaiting a 3 day longer culture grow tests on my possible UTI and immediately started feeling better.  Finally started sleeping again. Energy and mental clarity returned. Went for my next booster of rabies on 5/24/2020 in the arm at the same hospital. Within 30 minutes I felt the whole upper body skin burning sensation again but not as bad. The whole day I felt great.  Appetite which was non-existent the first 3 days returned finally too.   Today (5-26) I awoke feeling a little shaky again, arms and legs do feel off/strange - but no pins/needles in feet/hands or any other symptoms - the sensations comes and goes. As the day goes on it seems to slowly resolve.  Is this normal behavior of the vaccine? Temp is 99.1. I feel fine otherwise.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Poor quality sleep, SARS-CoV-2 test negative, Skin burning sensation
Clinical narrative: NOTE - I do not know which Rabies vac was used - it's not on my paperwork -   While one in a billion chance of obtaining rabies from bat spit out of the air when near a roosting site, my irrational mind went to the hospital when I awoke with what felt like flu symptoms in my arms and legs and I started immediate rabies treatment. 36 hours later I felt a sensation in my bladder that instead I may actually be having a UTI which would explain the odd arm/leg flu type chills I was having along with a very hard issue concentrating. I did have a UTI without bladder feeling before but it hit the kidney first with massive pain and while there was no pain this time, the aftermath felt familiar. I had also not slept very well for 60 hours.  Regardless, I started rabies treatment with the 2 shots in the legs of immunoglobulin and first dose of rabies vac in the arm. Type is only shown as purified chick embry cell (5/21/2020). I was also test for covid-19 the same morning as initial symptoms but came back negative.  After receiving my first pass at this vaccine, I woke up after a restless sleep the next morning feeling as if my skin was on fire. That lasted 20-30 minutes and subsided. Later that evening  is when I felt my bladder feeling weird and a home test shows elevated leukocytes so I went the next day to the local clinic to be tested. Initial quick test was negative but all my symptoms fit. I had no cough and temp has never gone over 100.1 and hovers around 98.9 and 99.1 - My baseline is 97.9. I've had on and off feeling of weird tension in my arms/legs but figure it was the shots themselves. By the evening, it was gone and I felt great.  I started Macrobid while awaiting a 3 day longer culture grow tests on my possible UTI and immediately started feeling better.  Finally started sleeping again. Energy and mental clarity returned. Went for my next booster of rabies on 5/24/2020 in the arm at the same hospital. Within 30 minutes I felt the whole upper body skin burning sensation again but not as bad. The whole day I felt great.  Appetite which was non-existent the first 3 days returned finally too.   Today (5-26) I awoke feeling a little shaky again, arms and legs do feel off/strange - but no pins/needles in feet/hands or any other symptoms - the sensations comes and goes. As the day goes on it seems to slowly resolve.  Is this normal behavior of the vaccine? Temp is 99.1. I feel fine otherwise.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: 5/23/20 fever chills achy all over  took Tylenol and Benadryl 5/24/20 starting feeling better but still in pain and developed rash on one foot still taking Tylenol and benaryl 5/26/20 reported symptoms to pharmacist.  pharmacist told patient to contact family doctor for follow-up.  this was the 2nd and last shingrix shot in series
Sex: F
Vaccine: HEP, HEPA, JEV1, TYP
Symptoms: Erythema, Skin disorder
Clinical narrative: Patient describes her face as "leathery" with a dark brown redness to her skin.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Shortly after the vaccine, my left arm became very painful to the point where I could not sleep on my left side, had trouble reaching or stretching, and a general muscle ache centering around the injection site and around and down my upper arm. Almost 60 days later it is getting steadily worse.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shortly after the vaccine, my left arm became very painful to the point where I could not sleep on my left side, had trouble reaching or stretching, and a general muscle ache centering around the injection site and around and down my upper arm. Almost 60 days later it is getting steadily worse.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: Employee began to feel symptomatic approximately 6 hours post vaccine. Employee felt pain at injection site on the day of vaccine. Next day Employee began to feel warmth, swelling, fatigue, headache, and redness at injection site which continues to this day. Employee has applied to ice to injection site which provides little relief and has taken ibuprofen.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: Employee began to feel symptomatic approximately 6 hours post vaccine. Employee felt pain at injection site on the day of vaccine. Next day Employee began to feel warmth, swelling, fatigue, headache, and redness at injection site which continues to this day. Employee has applied to ice to injection site which provides little relief and has taken ibuprofen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Localized erythematous welt (L) thigh.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Laboratory test normal, Pyrexia
Clinical narrative: -Shivering -fever -upset stomach -diarrhea FYI I was exposed to chicken pox as a child (9-10yrs) but did not get it.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Skin tightness, Skin warm
Clinical narrative: 3" circular reaction @ vaccine site Red, swollen, itchy Patient is a 5 year old female. Rash on the leg. Had WCC on Tuesday, received her Quadracel and later that night had developed redness and swelling around the site of injection. It has been itching, so treated with Benadryl with some relief of symptoms. However, today rash seems to be getting worse. Skin is tense and warm, no pain. No drainage. No fevers. Allergy list reviewed Medication reconciliation performed
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination site swelling
Clinical narrative: 3" circular reaction @ vaccine site Red, swollen, itchy Patient is a 5 year old female. Rash on the leg. Had WCC on Tuesday, received her Quadracel and later that night had developed redness and swelling around the site of injection. It has been itching, so treated with Benadryl with some relief of symptoms. However, today rash seems to be getting worse. Skin is tense and warm, no pain. No drainage. No fevers. Allergy list reviewed Medication reconciliation performed
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has reddened (L) arm, swollen, warm to touch
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: The patient experienced sores on the left arm  for about 3 days after she received the vaccine.  The pain comes and goes so far and the patient reported the side effects around 5 pm on 05/27/2020 to pharmacy manager.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: The patient experienced sores on the left arm  for about 3 days after she received the vaccine.  The pain comes and goes so far and the patient reported the side effects around 5 pm on 05/27/2020 to pharmacy manager.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported in the patient; patient received an expired dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 11-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) vial, 25/0.5 (units not provided) for prophylaxis, lot number: S002505 verified as valid, expiration date: 04-APR-2020 (exact dose and route of administration were not provided). No additional adverse effects were reported in the patient. The outcome of the event was unknown.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Dose of VARIVAX reconstituted with expired dose of STERILE DILUENT and admnistered to patient; Dose of VARIVAX reconstituted with expired dose of STERILE DILUENT and admnistered to patient; This spontaneous report was received from a medical assitant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 27-APR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R023504, which has been verified to be valid, expiration date unknown by the reported but validated as 16-AUG-2020) for prophylaxis (dosage schedule, vaccination scheme, route of administration and anatomical site of vaccination were not reported). According to the medical assistant, the administrated dose of the vaccine was reconstituted with an expired sterile diluent (lot number N028746, which has been verified to be valid, expiration date reported and validated as 17-MAR-2020) (expired product administered and product preparation error). Additionally, the medical assitant reported that the sterile diluent had no temperature excursions.  No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: Gardasil used to treat Recurrent Respiratory Papillomatosis; Literature Report:   Information has been received from the authors of a literature, titled as stated above, referring to a 12 years old female patient. The patient was diagnosed with juvenile onset recurrent respiratory papillomatosis (RRP). The affected sites included larynx, tracheal and pulmonary. The surgical interval between excisions for papilloma was 1-4 weeks. Numerous adjuvant treatments had been administered, including localized cidofovir, systemic interferon, systemic propranolol and systemic celecoxib.  On an unknown date, the patient was also vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, route, dose, frequency, lot number and expiration date unknown) to treat juvenile onset RRP (product use in unapproved indication).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; A patient who was born on 20-JAN-2020, was administered the first dose of ROTATEQ on 20-MAY-2020.; This spontaneous report was received from a registered nurse referring to a 4-month-old patient, whose gender was not specified. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 20-MAY-2020, being 4 months old,  the patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, for prophylaxis. (reported lot number S014947 has been verified to be valid; expiration date was not reported, but upon internal validation it has been established as 10-DEC-2020.) (inappropriate schedule of product administration). There were not known adverse events according to the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported.; a patient was administered a second dose of VARIVAX at an extended interval after the first dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, previous drug reactions and drug allergies were not reported. Concomitant therapies included sterile diluent.  On 01-MAY-2018, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On 23-AUG-2019, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, lot # S010296, expiration date not reported, but upon internal validation established as 03-APR-2021 (strength, dose and frequency, were not reported); as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; unspecified 14 year old male was inadvertently administered an expired dose of GARDASIL 9; Lot Number N021571 is NOT valid for GARDASIL 9, it is valid for GARDASIL; This spontaneous report was received from a licensed practical nurse referring to a 14 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 19-MAY-2020, the patient was inadvertently vaccinated with an expired dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot #N021571 (verified to be a valid lot number), expiration date reported and stablished as 29-APR-2020. No adverse effects were reported.  (It was reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot #N021571 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, lot# N021571 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)).
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: patient was administered ROTATEQ and regurgitated some of the ROTATEQ; patient was administered ROTATEQ and regurgitated some of the ROTATEQ; This spontaneous report was received from a medical assistant, referring to a 9-week-old female patient. The patient had none pertinent medical history, concomitant medications, drug reactions, or allergies.  On 20-MAY-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (vaccination scheme was not reported; lot number 1660951, which has been verified to be valid, expiration date reported and validated as 11-NOV-2020), administered orally as prophylaxis, and regurgitated some of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (regurgitation and underdose).  It was reported that the patient did not seek medical attention, treatment was not given, and none laboratory diagnostics/studies were performed.  The patient recovered from regurgitation the same day of vaccination. The causal relationship between therapy with vaccine, live, oral, pentavalent (ROTATEQ) and regurgitation was not provided.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: two female patients fainted and had seizures; two female patients fainted and had seizures; This initial spontaneous report was received from a Henry Schein refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 19-MAY-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot/ batch number and expiry date were not reported) for prophylaxis. On 19-MAY-2020 (also reported as "after being injected with vaccination), the patient fainted (syncope) and experienced seizures. The outcome of syncope and seizure was unknown. Causality assessment was not provided.  Upon internal review, the events syncope and seizure were determined to be medically significant.  This is one of the two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA008420:
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: two female patients fainted and had seizures; two female patients fainted and had seizures; This initial spontaneous report was received from a Henry Schein refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 19-MAY-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot/ batch number and expiry date were not reported) for prophylaxis. On 19-MAY-2020 (also reported as "after being injected with vaccination), the patient fainted (syncope) and experienced seizures. The outcome of syncope and seizure was unknown. Causality assessment was not provided.  Upon internal review, the events syncope and seizure were determined to be medically significant.  This is one of the two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA008018:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported.; Nurse called reporting improperly stored VARIVAX was administered to patient on 21-MAY-2020.; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not reported.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) (lot number S012036, which has been verified to be valid, expiration date reported and validated as 17-APR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The administered dose of the vaccine experienced a temperature and time frame of 48.2 degrees Fahrenheit for 4 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported.; Nurse called reporting improperly stored VARIVAX was administered to patient on 15-MAY-2020.; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not reported.  On 15-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) (lot number S012036, which has been verified to be valid, expiration date reported and validated as 17-APR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The administered dose of the vaccine experienced a temperature and time frame of 48.2 (units not reported) for 4 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.; Sender's Comments:  US-009507513-2005USA008243:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pyrexia
Clinical narrative: Feverish; It has been more than 6 months since they both received the first dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 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 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and incomplete course of vaccination. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of vaccine in November 2019 and experienced feverish symptoms.  Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2020085243, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pain
Clinical narrative: Injection site pain; Body aches; Feels miserable; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 1st dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling miserable. On an unknown date, the outcome of the injection site pain, general body pain and feeling miserable were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site along with arm was very sore, body aches and feels miserable.  The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: On unspecified date, the patient developed shingles On25th April the patient taken unspecified antiviral. At the time of reporting the patient had no rash and no symptoms. The health care professional did not have the lot number since the 1st dose was not given at his pharmacy. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a nurse via call center representative and described the occurrence of fever in a 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. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a fever after Shingrix vaccine. The dose number was not clear whether 1st dose of Shingrix or 2nd dose of Shingrix. The reporter did not provided any other details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; warmth at injection site; swelling under arm; pain in under arm; slept all day; headache; chills; injection site pain/tenderness in her arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoporosis. Concomitant products included sodium ibandronate (Boniva).   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 18th May 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and chills. On 19th May 2020, the patient experienced sleepiness. On an unknown date, the patient experienced injection site swelling, injection site warmth, enlargement of lymph nodes and axillary pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the sleepiness, headache and chills were recovered/resolved and the outcome of the enlargement of lymph nodes and axillary pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain, sleepiness, headache, chills, enlargement of lymph nodes and axillary pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On 18th May 2020, after receiving the Shingrix vaccine the patient experienced chills, headache and pain at the injection site. On 19th May 2020, 1 day after receiving the vaccine, the patient was slept all day, and the chills and headache started resolving around bedtime.  The patient still had tenderness in her arm at the injection site and under her arm. It was warm to the touch at the injection site and she has swelling under her arm near her breast.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lymphadenopathy, Somnolence, Swelling
Clinical narrative: swelling at injection site; warmth at injection site; swelling under arm; pain in under arm; slept all day; headache; chills; injection site pain/tenderness in her arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoporosis. Concomitant products included sodium ibandronate (Boniva).   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 18th May 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and chills. On 19th May 2020, the patient experienced sleepiness. On an unknown date, the patient experienced injection site swelling, injection site warmth, enlargement of lymph nodes and axillary pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the sleepiness, headache and chills were recovered/resolved and the outcome of the enlargement of lymph nodes and axillary pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain, sleepiness, headache, chills, enlargement of lymph nodes and axillary pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On 18th May 2020, after receiving the Shingrix vaccine the patient experienced chills, headache and pain at the injection site. On 19th May 2020, 1 day after receiving the vaccine, the patient was slept all day, and the chills and headache started resolving around bedtime.  The patient still had tenderness in her arm at the injection site and under her arm. It was warm to the touch at the injection site and she has swelling under her arm near her breast.  The reporter consent to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: pain at injection site; muscle achiness; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th May 2020, 2 hrs after receiving Shingrix, the patient experienced injection site pain, myalgia and tiredness. On an unknown date, the outcome of the injection site pain, myalgia and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient experienced pain at the injection site, feeling tired, and muscle achiness approximately two hours after the injection. Consented to follow up. The reporter consent to follow up.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Syringe issue, Underdose
Clinical narrative: at least half of the volume was administered; Syringe leak; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced accidental underdose and syringe leak. On an unknown date, the outcome of the accidental underdose and syringe leak were unknown.  Additional details were reported as follows: The age at vaccination was not reported. While receiving the Pediarix vaccine the needle came out and only half of the volume was administered which led to accidental under dose and syringe leak.  No further details were provided.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Haematochezia, Intussusception, Occult blood positive, Salmonella test negative, Vomiting
Clinical narrative: Vomiting; blood in the stool / bloody bowel movements; Possible Intussusception; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 3-month-old male patient who received Rota (Rotarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, HAEMOPHILUS INFLUENZA B VACCINE (HIB VACCINE) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   Concurrent medical conditions included breast feeding.   On 7th May 2020, the patient received the 1st dose of Rotarix (oral), the 1st dose of Pediarix, HIB VACCINE and PREVNAR. On 9th May 2020, 2 days after receiving Rotarix and Pediarix, the patient experienced blood in stool (serious criteria GSK medically significant) and intussusception (serious criteria GSK medically significant). On 20th May 2020, the patient experienced vomiting. On an unknown date, the outcome of the blood in stool, intussusception and vomiting were unknown.   It was unknown if the reporter considered the blood in stool, intussusception and vomiting to be related to Rotarix and Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported that, 2 days after receiving Rotarix, Pediarix, Prevnar and Hib vaccine, she noticed blood in the stool. MD informed her to keep breast feeding.  They visited on 18th May 2020 and a hemoccult was performed, which was positive, and a stool culture was also performed to rule out Salmonella.  She stated that at that time, the patient appeared to be normal with normal stool (yellow from breast feeding).  The day before reporting, the patient fed well, but the mother called on the day of reporting stating that the patient was vomiting after each feeding.  PI information was provided regarding bloody bowel movements and vomiting, which could be a sign of intussusception.  MD stated that she would be seeing the patient again on the day of reporting and would probably refer to the ED.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash & RASH
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a female patient who received DTPa (Reduced antigen) (Boostrix) for product used for unknown indication.   On an unknown date, the patient received Boostrix (unknown). On an unknown date, an unknown time after receiving Boostrix, the patient experienced adverse event. The action taken with Boostrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Boostrix.  Additional information: On May 22, 2017, based on the information from GSK's advertisement that receiving this product could help plaintiff protect her newborn granddaughter, the plaintiff expended time and resources to travel to her local pharmacy where she requested and was injected with this product. The Plaintiff later found out that the information she received from GSK's advertising campaign is false and misleading because while this product may provide some protection in the recipient from manifesting symptoms of pertussis, it does not prevent asymptomatic infection and silent transmission of pertussis.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: 99-100 degree fever, muscle aches, lethargy
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Child was given Kinrix and Pediarix .   Call place to parent to let them know what to look for signs and symptoms
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Hemiparesis, Sensory loss
Clinical narrative: transcient cerebral ischemic attack; 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. In or around 26-OCT-2016, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), patient experienced left-sided hemiparesis. The patient was hospitalized and diagnosed with possible transient cerebral ischemic attack, left facial droop, left hemisensory loss and left sided weakness. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, 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. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of transient cerebral ischemic attack was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of transient cerebral ischemic attack was considered to be disabling. Upon internal review, the event of transient cerebral ischemic attack was considered do be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S012036, expiration date: 17-APR-2021 (strength, dosage schedule and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature 48.2 (units not provided) for 4 hours- as recorded by digital data logger. No previous excursion was noted. No adverse effects reported.