chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood glucose normal, Blood magnesium normal, Blood pressure increased, Full blood count normal
Clinical narrative: Patient reports receiving 2nd COVID vaccine 3/17/2021, presented with 5 days of burning all over worse in the feet x 5 days 3/25/2021. Reports it's so bad keeps her up at night, mild relief when taking a cold shower, then returns. Reports given antihistamines from PCP , BP was elevated, and thyroid studies and A1C tests and they were normal, medication isn't helping. Physical exam normal. VS WNL, BP slightly elevated 130/90. Given steroid injection and prescription, neurology referral. CBC, CMP, Magnesium, Sed Rate, CRP labs ordered. CBC and Magnesium were normal. CRP/Sed rate were unable to performed due to age of specimen. CMP showed elevated glucose/creatinine, decreased GFR. provider that received those results referred pt to nephrology.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Glycosylated haemoglobin, Metabolic function test, Physical examination normal, Skin burning sensation
Clinical narrative: Patient reports receiving 2nd COVID vaccine 3/17/2021, presented with 5 days of burning all over worse in the feet x 5 days 3/25/2021. Reports it's so bad keeps her up at night, mild relief when taking a cold shower, then returns. Reports given antihistamines from PCP , BP was elevated, and thyroid studies and A1C tests and they were normal, medication isn't helping. Physical exam normal. VS WNL, BP slightly elevated 130/90. Given steroid injection and prescription, neurology referral. CBC, CMP, Magnesium, Sed Rate, CRP labs ordered. CBC and Magnesium were normal. CRP/Sed rate were unable to performed due to age of specimen. CMP showed elevated glucose/creatinine, decreased GFR. provider that received those results referred pt to nephrology.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test normal
Clinical narrative: Patient reports receiving 2nd COVID vaccine 3/17/2021, presented with 5 days of burning all over worse in the feet x 5 days 3/25/2021. Reports it's so bad keeps her up at night, mild relief when taking a cold shower, then returns. Reports given antihistamines from PCP , BP was elevated, and thyroid studies and A1C tests and they were normal, medication isn't helping. Physical exam normal. VS WNL, BP slightly elevated 130/90. Given steroid injection and prescription, neurology referral. CBC, CMP, Magnesium, Sed Rate, CRP labs ordered. CBC and Magnesium were normal. CRP/Sed rate were unable to performed due to age of specimen. CMP showed elevated glucose/creatinine, decreased GFR. provider that received those results referred pt to nephrology.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms, 18 to 20 hours after injection. Feverish, chills, muscular aches, sensitive skin, headache. Symptoms disappeared approx. 15 hours after appearing.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Flu like symptoms, 18 to 20 hours after injection. Feverish, chills, muscular aches, sensitive skin, headache. Symptoms disappeared approx. 15 hours after appearing.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: measles like rash, upper arms, upper legs, thighs, buttocks, sides, breasts, upper abdomen appeared a couple of days after first injection, then within a few hours of second shot, heavier. There is little to no itching or discomfort, was accompanied by headache, which continue starting late evening daily. Fatigue and muscle and joint aches, plus low grade fever started 10 to 12 hours after each injection and lasted about 2 1/2 to 3 days.  Second shot was administered 3/24/2021 5:30 PM
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash morbilliform
Clinical narrative: measles like rash, upper arms, upper legs, thighs, buttocks, sides, breasts, upper abdomen appeared a couple of days after first injection, then within a few hours of second shot, heavier. There is little to no itching or discomfort, was accompanied by headache, which continue starting late evening daily. Fatigue and muscle and joint aches, plus low grade fever started 10 to 12 hours after each injection and lasted about 2 1/2 to 3 days.  Second shot was administered 3/24/2021 5:30 PM
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient came in with his wife for our 2nd shot clinic. They arrived this morning and filled out their questionnaire . We did not look to see that his appointment was on 04/29/21 and they had just got their first shots on 04/02. When we noticed later  I contacted him and he said that he heard next week and not 4 weeks away.  When he looked at his card it did say  04/29/21 for 2nd shot. They got confused and we did not notice it in the process. I contacted manufacturer and his physician. At the time I spoke with them neither was having any issues.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head, Dizziness, Electrocardiogram, Laboratory test
Clinical narrative: Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Seizure like phenomena, Vision blurred
Clinical narrative: Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: client complained of headache after receiving 1st Moderna Covid Vaccine (lot 041B21A Exp. 5/6/21). Client was leaving after completing 20 min observation when he approached PHN and asked if he could leave. When PHN asked how he was feeling, client mentioned headache that begun after receiving vaccine. Client was asked to sit down for further assessment. 1238 vitals: blood pressure/90, pulse 77, oxygen 96%. Medical history: chronic migraines, sleep apnea, chronic back pain, and joint pain. Client unable to provide medication names. Client alert and oriented. Headache feels same as when a migraine is starting. Denied chest pain, blurry vision, no dizziness. Headache pain 1/10, described as "pressure" to back of head. Client wanted to leave, PHN spoke to client regarding high blood pressure, per client it was fine. PHN  gave ER precautions and advised to see primary care provider regarding blood pressure. Client left facility at 1248 with steady gait.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaemia, Pain in extremity
Clinical narrative: arm soreness and focal hyperemia with diarrhea, starting the day of vaccination, and continuing at least until report date
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Fever over 100F Severe headache  Fatigue  Body aches  Dizziness brain fog  Impatience  Onset - Approximately 4 hours after 2nd dose. Getting worse over the next 12 hours then persisting for the next 36 hours.  Headache is less severe and fever has reduced now that its 48 hours past.  Still not feeling well. Dizziness, brain fog, fatigue, Body aches and mild headache persists.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever over 100F Severe headache  Fatigue  Body aches  Dizziness brain fog  Impatience  Onset - Approximately 4 hours after 2nd dose. Getting worse over the next 12 hours then persisting for the next 36 hours.  Headache is less severe and fever has reduced now that its 48 hours past.  Still not feeling well. Dizziness, brain fog, fatigue, Body aches and mild headache persists.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness
Clinical narrative: Patient reported feeling dizzy, nauseated,  Loss of hearing and lightheaded ness  Patient seen by medical team, refused medical transport, stated symptoms improved, signed AMA form
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Malaise, Tachypnoea
Clinical narrative: Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: pain in rt shoulder, unable to lift arm above head without pain..tried moist wrap; Tylenol, but not much relief.  the symptoms are more severe in the early A>M>, but is much less in the midafternoon;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: I took the second shot and remembered I felt the onset of my arm pain and dizziness the next day.  So, this time, I stayed awake until 12 hours after the shot to catch the pain as soon as possible. I didn't take medication after the first shot, but this time, I planned to take Tylenol.  I briefly fell asleep for a few hours and woke up at 3:30 a.m.  Around 3:30 am, I felt a little headache, so I took one extra strength Tylenol.    Around 6:00 pm Tuesday evening, I began to feel a little soreness at the injection site for my 2nd COVID vaccination, which was in my right arm.  For some reason, I also started to feel muscle soreness (similar to the way I felt after the first COVID vaccination), but it was in my left arm (which I did not get the shot for this second vaccination).  I also began feeling pain in my neck.  So I took another extra strength Tylenol.  I also stretched my arms and did pushups, jogged a bit, drank water and massaged my arms.  Then, on Wednesday morning around 8:00 am, my left arm felt the same muscle soreness.  So, I took two extra strength Tylenols.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Confusion reported
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Nausea
Clinical narrative: Extremely Dizzy like when you get off an airplane and blow your nose to equalize pressure, head pressure and nausea. Nausea started 20 minutes after shot but went away, dizziness started about 30 minutes after and became progressively worse. Stayed in bed, hydrated well, ate..etc.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Skin warm, Urticaria
Clinical narrative: Approx 3 minutes s/p 1st vaccination, pt c/o hotness and  Pruritis to R forehead.  `1 urticaria noticed (the size of a quarter) redness and itching present at site. Pt denies shortness of breath, chest discomfort, heaviness of the tongue, or swelling of the throat.  Upon exam VSS SBP/ 134/90 HR 58 R 18 O2 99% on R T 98.1, Uvula midline, no wheezing heard, no swelling of the tongue or lips noted, pt does not have urticaria present anywhere else on body, PE benign.  Secondary, to history of allergies (seasonal and shrimp) for which he is under the care of an allergist, Benadryl 50mg po was adminstered at 10:11, with resolution of urticaria 10:41
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Dizziness, headache, nausea, foggy head
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Headache, Magnetic resonance imaging head
Clinical narrative: Dizziness, headache, nausea, foggy head
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dizziness, Limb discomfort
Clinical narrative: Approximately 8 min after receiving vaccine patient reports Tightness in chest and limbs, light headed, anxious
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After 10 minutes, patient complained that her arm had gone progressively numb.  I asker her to remain another 10 minutes and there was no improvement.  She wanted to go home, so I told her that I would call her in 2 hours.  When I spoke to her 2 hours later, the arm had returned to normal with no impaired function
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Paraesthesia, Peripheral swelling, Rash erythematous
Clinical narrative: VACCINE WAS ADMINISTERED AT 9:33 AM. PATIENT WAITED 30 MINUTES AND LEFT AT 10:00AM. PATIENT RETURNED TO PHARMACY AT 10:45AM STARTING SHE STARTED HAVING A REACTION AROUND 10:30AM. PATIENT WAS TINGLY, BOTH ARMS WERE SWELLING AND HAD A RED RASH, AND SCRATCHY THROAT. PATIENT ALSO FELT WEAKNESS IN BOTH ARMS AND FATIGUE. BENEDRYL 50 MG WAS ADMINISTERED AT 10:45 AM BY MOUTH. PATIENT WAITED FOR 30 MINUTES DID NOT RESPOND TO BENEDRYL.  PRIMARY DOCTOR WAS PHONED AND HE RECOMMENDED ADMINISTERING EPINEPHERINE. EPINEPHERINE WAS ADMINISTERED AT 11:15 AM IN RIGHT THIGH. PATIENT WAITED 5 MINUTES AND STABILIZED. PATIENT LEFT PHARMACY AT 11:20AM
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: VACCINE WAS ADMINISTERED AT 9:33 AM. PATIENT WAITED 30 MINUTES AND LEFT AT 10:00AM. PATIENT RETURNED TO PHARMACY AT 10:45AM STARTING SHE STARTED HAVING A REACTION AROUND 10:30AM. PATIENT WAS TINGLY, BOTH ARMS WERE SWELLING AND HAD A RED RASH, AND SCRATCHY THROAT. PATIENT ALSO FELT WEAKNESS IN BOTH ARMS AND FATIGUE. BENEDRYL 50 MG WAS ADMINISTERED AT 10:45 AM BY MOUTH. PATIENT WAITED FOR 30 MINUTES DID NOT RESPOND TO BENEDRYL.  PRIMARY DOCTOR WAS PHONED AND HE RECOMMENDED ADMINISTERING EPINEPHERINE. EPINEPHERINE WAS ADMINISTERED AT 11:15 AM IN RIGHT THIGH. PATIENT WAITED 5 MINUTES AND STABILIZED. PATIENT LEFT PHARMACY AT 11:20AM
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Patient reported feeling dizzy about 5 minutes after receiving vaccination.  He then fainted immediately after reporting that.  We got him to the ground safely with feet up and used a cold pack. He regained consciousness quickly.  He sat up about 10 minutes later and left about 15-20 minutes later.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Fatigue, Headache
Clinical narrative: Chest pain, numbness in left arm, and left leg. President headaches and fatigue for over two weeks after vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Chest pain, numbness in left arm, and left leg. President headaches and fatigue for over two weeks after vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: fever, headache, generalized body aches, chills, nausea, "felt horrible, awful, terrible",  sent to EC for evaluation and discharged
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever, headache, generalized body aches, chills, nausea, "felt horrible, awful, terrible",  sent to EC for evaluation and discharged
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test normal, Computerised tomogram normal, X-ray normal
Clinical narrative: Bell's palsy - left side of face.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injury associated with device, Scratch
Clinical narrative: Vaccinator had a reverse needlestick. Vaccinator did not realize that he was stuck first. Vaccinator was scratched on his left hand then gave the vaccine to the patient's arm. After giving the vaccine, vaccinator realized that his left 2nd digit was scratched and saw a little bit of blood.   Treatment: Washed the wound site with soap and water. Reported incident to supervisor. Sought medical treatment to nearest ER for patient and staff member.   Outcome: Both patient and staff member has no other symptoms. not in distress. Awaiting for lab results.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Client complained of being light headed and tightness in his chest.  Client reports history of panic attacks which resulted in similar symptoms.  Gave a bottle of water to drink.  Lightheadness and tightness in chest subsided quickly.  Clients BP at 11:15 164/84.  Has history of borderline hypertension.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Pharyngeal swelling, Pruritus
Clinical narrative: runny nose, tight chest, throat swelling, rash, itchy arms, 0.3 mg epipen, benedryl in right arm, steroid in left thigh (folumeerol) chills, diarrhea
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea
Clinical narrative: runny nose, tight chest, throat swelling, rash, itchy arms, 0.3 mg epipen, benedryl in right arm, steroid in left thigh (folumeerol) chills, diarrhea
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Incoherent, Pallor, Seizure
Clinical narrative: Approximately 5 minutes after vaccine patient felt lightheaded. Pharmacist immediately checked on patient who was beginning  to become incoherent.  He had a mild seizure and ems was called.  Patient was sweating and pale.  He remained onsite with EMS and later left with a family memeber.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills, fever, fatigue, decrease in oxygen saturation to 91-92%
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Peripheral coldness, SARS-CoV-2 test positive, Visual impairment
Clinical narrative: patient left vaccination site 15 minutes post-vaccination and noticed vision "was different" while driving, then returned to vaccination site. Upon return to vaccination site, reported chest "felt heavy" and left arm felt cold
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Preterm premature rupture of membranes
Clinical narrative: Preterm premature rupture of membranes at 18 weeks gestation (due date 9/4), resulting in pregnancy loss
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Had diarrhea for 7 days worried that her second shot would cause the same problems, also her mom died from COVID
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache began 4/3/21 and got progressively worse to be a serve headache with nausea and vomiting by 4/6/21. On 4/8/21 I visited my PCP and received a phenergan shot and toradol shot.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotonia, Immediate post-injection reaction, Orthostatic hypotension, Pallor
Clinical narrative: Immediately after injection, patient got pale and slid down in his chair.  Health staff eased him to the ground and he came to in about 30 seconds.  He was brought into clinic in a gurney and  initially exhibited orthostatic hypotension. After he was given electrolytes and water, he felt much  better.  He was observed for about an hour and bp was stable so he was released.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: When I received the vaccination, I began to experience numbness and tingling in my left arm.  The numbness and tingling radiate down to my fingers- the ring finger and the pinky finger.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness
Clinical narrative: Patient reported feeling shaky and dizzy Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved Patient driven home by family
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: 5x7cm raised area of well-circumscribed erythema, warmth, itching to lateral left upper arm, 1-2cm below vaccine injection site onset approximately 1 day after vaccination  (timing per patient report.) Presented to clinic for evaluation 1.5 weeks after onset due to persistent symptoms. Also with few scattered small erythematous papules to right (opposite) arm.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Syncope
Clinical narrative: Syncope for 15-30 sec. head trauma. Neg. concussion screen test.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: The day following receiving the vaccine I had no appetite whatsoever and was fatigued. The symptoms were similar to when I had Covid in November 2020 except I also had fever at that time. I did not treat the symptoms and they went away by the next morning.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no PQC or additional Adverse Events Reported; Caller reported vaccine administered after temperature excursion.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender.  No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 29-MAR-2021, the patient was administered 2 ml orally of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot 1691300 and expiration date 24-NOV-2021 for prophylaxis (dose number and vaccination schemes frequency were not reported). The involved vaccine underwent a temperature excursion of 11.7 degrees Celsius for 75 minutes. A data logger was used.  At the time of the report no adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same source. 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.; devicelotnumber: 1614898; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001253: US-009507513-2104USA001254:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no known side effects; Expired proquad was given; This spontaneous report has been received from a nurse referring to a 5 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 29-MAR-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S030211 with expiration date of 25-MAR-2021 (strength, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. No adverse events reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: fever of 100; intense pain in the upper arms, both arms, with intense shoulder and upper arm pain; intense shoulder and upper arm pain; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On 17th April 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain in arm and shoulder pain. On an unknown date, the outcome of the fever, pain in arm and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient and her family did not have any medical history. The patient received the dose of Shingrix might be in her left arm and experienced fever of 100 degree F and intense pain in the upper arms, both arms, with intense shoulder and upper arm pain. On 21st March 2021 the patient received the dose of Covid-19 vaccine and 9 days after the vaccination on 30th March 2021 patient experienced Itching at vaccination site, swelling the size of a chicken or goose egg and also injection site was warm and red. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shingles shot and still ended up with them twice.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had the shingles shot and still ended up with shingles twice. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shot and have the Shingles; This case was reported by a consumer via interactive digital media (facebook)and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Shingles. The reporter reported its hates to bust bubble. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary vaccination schedule for shingles, and laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Varicella post vaccine
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter was patient's friend. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated his or her friend got the shingles even after receiving the shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary vaccination schedule for shingles, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter was patient itself. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles and it was so painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary vaccination schedule for shingles, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got vaccinated still got shingles/ suspected Vaccination failure; Got vaccinated still got shingles; hurt like no bodies business; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got vaccinated with shingles vaccine still got shingles, not a raging case non the less got them and it hurt like nobody's business. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late second doses/first dose on Feb 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked with case US2021075958, reported for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075958:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shingles shot and still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. This case was reported by the patient. The patient took the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Groin pain, Injection site pain, Pain of skin, Rash pruritic, Sensitive skin
Clinical narrative: large rash/hives on either side of his rib cage which was itchy; large rash/hives on either side of his rib cage; sides where the rash/hive were located is still sensitive to the touch; significant jock itch which primarily included his scrotum / scrotum is still painful to touch and itchy; scrotum is still painful to touch; scrotum is still painful to touch and itchy; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis (was taking humira for psoriatic arthritis for about 10 years). Concomitant products included adalimumab (Humira).   On 12th January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix and an unknown time after starting Lotrimin, the patient experienced injection site pain. On 15th January 2021, the patient experienced itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male. The patient was treated with clotrimazole (Lotrimin) and avena sativa (Aveeno Lotion). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the itchy rash, hives and sensitive skin were unknown and the outcome of the tinea cruris, tenderness and genital itching male were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and had injection site pain in right arm for a day which then resolved.  The patient developed a large rash and hives on either side of rib cage which was itchy.  The rash and hives did resolve but both the sides where the rash and hive were located was still sensitive to the touch.  The patient developed significant jock itch which primarily included scrotum and scrotum was still painful to touch and itchy.  The patient applied Lotrimin on and off on scrotum which had not helped.  The patient was also applying Aveeno lotion.  The patient had not yet spoken to physician. The reporter stated that the patient was due for the second dose of the Shingrix vaccine on 14thApril 2021 and received the 1st dose of the Moderna COVID vaccine on 18th February 2021. The reporter did not had the lot number. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinea cruris, Urticaria
Clinical narrative: large rash/hives on either side of his rib cage which was itchy; large rash/hives on either side of his rib cage; sides where the rash/hive were located is still sensitive to the touch; significant jock itch which primarily included his scrotum / scrotum is still painful to touch and itchy; scrotum is still painful to touch; scrotum is still painful to touch and itchy; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis (was taking humira for psoriatic arthritis for about 10 years). Concomitant products included adalimumab (Humira).   On 12th January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix and an unknown time after starting Lotrimin, the patient experienced injection site pain. On 15th January 2021, the patient experienced itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male. The patient was treated with clotrimazole (Lotrimin) and avena sativa (Aveeno Lotion). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the itchy rash, hives and sensitive skin were unknown and the outcome of the tinea cruris, tenderness and genital itching male were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, itchy rash, hives, sensitive skin, tinea cruris, tenderness and genital itching male to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and had injection site pain in right arm for a day which then resolved.  The patient developed a large rash and hives on either side of rib cage which was itchy.  The rash and hives did resolve but both the sides where the rash and hive were located was still sensitive to the touch.  The patient developed significant jock itch which primarily included scrotum and scrotum was still painful to touch and itchy.  The patient applied Lotrimin on and off on scrotum which had not helped.  The patient was also applying Aveeno lotion.  The patient had not yet spoken to physician. The reporter stated that the patient was due for the second dose of the Shingrix vaccine on 14thApril 2021 and received the 1st dose of the Moderna COVID vaccine on 18th February 2021. The reporter did not had the lot number. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 56 year old patient who received one dose of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received infanrix instead of boostrix at the age of 56 ,which led inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an elderly male patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine and Shingle's vaccine.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had received the shingles vaccine a couple of years ago and he had shingles six times already. The reporter stated that the patient received the vaccine from his druggist. The patient took the 'first two' and then they told them about the second one, the reporter was referring to shingles vaccine but did not know the name of the vaccine when asked. The reporter stated she was told there was a better one a year later. The reporter did not provide further information about patient's adverse event. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up and did not provide the healthcare providers details.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on January 10th 2020 / second dose has not been administered ye; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 10th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. A patient had 1st dose of Shingrix on 10th January 2020 and the 2nd dose had not been administered yet which led to incomplete course of vaccination. The reporter did not consent to follow-up and follow up declined.  No lot number or expiration date provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first Shingrix / on August 17, 2020 / has not had the second / yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided as follow: The age at vaccination was not applicable for this report. No Lot number or expiration date for the 1st dose of Shingrix was available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.. The reporter did not consent to follow up.
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was administrated by error Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that a 11 months old patient was administered Kinrix by error, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 years and month baby was administrated by error Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 2 years patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.