chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal stenosis, Pain, Peripheral swelling, Swelling face, Swollen tongue
Clinical narrative: 2/18/2021 Patient received her 2nd dose of Moderna vaccine at 1230pm in the medical clinic examination room.  At 1245pm, patient complained of dizziness 15 minutes after her injection.  I advised her to sit and continue observation for another 15 minutes. At the same time, VS was taken in the examination room.  She walked with steady gaits, conversing with me, and denied shortness of breath.   After taking her VS, she was directed back to sit in the medical clinic for further observation.  Patient was talking and drank some water from the water bottle.  After 10 minutes, patient stated that she felt better and ready to go back to work.  When she was about to leave the medical clinic area around 1255pm, she developed a nosebleed on her right nostril.  I assisted patient in the bathroom to apply pressure on the right side of the nostril to stop the bleeding.  Patient and I stayed in the clinic for approximately another 15 minutes to stop the nosebleed.  Her nose bleed subsided, and she was ready to return to work.  I explained to patient that she may feel sore and body ache after her 2nd dose of the vaccine.  Patient had no further questions and left the medical clinic area around 115pm.  2/19/2021 Patient came to work this morning and mentioned to (name) who was in line for screening that she woke up with pain and swollen of her left side of her face.  (name)  reported patient complaint to (name) , Director of Nursing.  (name)  advised (name)  to report the issue to the GMO on call.  Doctor directed patient to seek medical attention from her primary care doctor.   (name)  notified patient and her supervisor - (name) .   Patient came up to the administration area and she told (name)  and (name)  that she wanted her brother to take her to the hospital.   She left the Hospital and went to UMC accompanied by her brother around 930am.   UMC called (name)  at the request of patient that she is in the emergency room and getting a full workup.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tongue oedema, Vaccination complication, Venous occlusion
Clinical narrative: 2/18/2021 Patient received her 2nd dose of Moderna vaccine at 1230pm in the medical clinic examination room.  At 1245pm, patient complained of dizziness 15 minutes after her injection.  I advised her to sit and continue observation for another 15 minutes. At the same time, VS was taken in the examination room.  She walked with steady gaits, conversing with me, and denied shortness of breath.   After taking her VS, she was directed back to sit in the medical clinic for further observation.  Patient was talking and drank some water from the water bottle.  After 10 minutes, patient stated that she felt better and ready to go back to work.  When she was about to leave the medical clinic area around 1255pm, she developed a nosebleed on her right nostril.  I assisted patient in the bathroom to apply pressure on the right side of the nostril to stop the bleeding.  Patient and I stayed in the clinic for approximately another 15 minutes to stop the nosebleed.  Her nose bleed subsided, and she was ready to return to work.  I explained to patient that she may feel sore and body ache after her 2nd dose of the vaccine.  Patient had no further questions and left the medical clinic area around 115pm.  2/19/2021 Patient came to work this morning and mentioned to (name) who was in line for screening that she woke up with pain and swollen of her left side of her face.  (name)  reported patient complaint to (name) , Director of Nursing.  (name)  advised (name)  to report the issue to the GMO on call.  Doctor directed patient to seek medical attention from her primary care doctor.   (name)  notified patient and her supervisor - (name) .   Patient came up to the administration area and she told (name)  and (name)  that she wanted her brother to take her to the hospital.   She left the Hospital and went to UMC accompanied by her brother around 930am.   UMC called (name)  at the request of patient that she is in the emergency room and getting a full workup.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Vaccination complication
Clinical narrative: 2/18/2021 Patient received her 2nd dose of Moderna vaccine at 1230pm in the medical clinic examination room.  At 1245pm, patient complained of dizziness 15 minutes after her injection.  I advised her to sit and continue observation for another 15 minutes. At the same time, VS was taken in the examination room.  She walked with steady gaits, conversing with me, and denied shortness of breath.   After taking her VS, she was directed back to sit in the medical clinic for further observation.  Patient was talking and drank some water from the water bottle.  After 10 minutes, patient stated that she felt better and ready to go back to work.  When she was about to leave the medical clinic area around 1255pm, she developed a nosebleed on her right nostril.  I assisted patient in the bathroom to apply pressure on the right side of the nostril to stop the bleeding.  Patient and I stayed in the clinic for approximately another 15 minutes to stop the nosebleed.  Her nose bleed subsided, and she was ready to return to work.  I explained to patient that she may feel sore and body ache after her 2nd dose of the vaccine.  Patient had no further questions and left the medical clinic area around 115pm.  2/19/2021 Patient came to work this morning and mentioned to (name) who was in line for screening that she woke up with pain and swollen of her left side of her face.  (name)  reported patient complaint to (name) , Director of Nursing.  (name)  advised (name)  to report the issue to the GMO on call.  Doctor directed patient to seek medical attention from her primary care doctor.   (name)  notified patient and her supervisor - (name) .   Patient came up to the administration area and she told (name)  and (name)  that she wanted her brother to take her to the hospital.   She left the Hospital and went to UMC accompanied by her brother around 930am.   UMC called (name)  at the request of patient that she is in the emergency room and getting a full workup.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site reaction
Clinical narrative: Redness at site of vaccine with an area about one inch radius of point of insertion. Itchiness at site of vaccine. No treatment sought.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea
Clinical narrative: 10:45 pt reported not feeling well; He complained of feeling nauseas and weak. Assisted pt to lie down on cot;  Nursing assessment done, vital signs taken, pt offered water, history taken from pt and wife; mental status assesed; 911 called;RN    stayed with pt until EMS took pt to hospital via ambulance for further evaluation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on thighs, torso and arms
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, C-reactive protein increased, Coagulopathy
Clinical narrative: Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination.   He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A).  He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies.  He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome.  He was ultimately discharged to outpatient care with ongoing supportive care for his fevers.  His liver associated enzymes were improving at discharge.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis, Interleukin level increased, International normalised ratio increased, Prothrombin time prolonged, Pyrexia
Clinical narrative: Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination.   He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A).  He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies.  He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome.  He was ultimately discharged to outpatient care with ongoing supportive care for his fevers.  His liver associated enzymes were improving at discharge.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive, Systemic inflammatory response syndrome
Clinical narrative: Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination.   He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A).  He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies.  He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome.  He was ultimately discharged to outpatient care with ongoing supportive care for his fevers.  His liver associated enzymes were improving at discharge.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy rash on chest and hives on chest. No treatment other than topical anti itch cream. Itching stopped after 24 hours. Still have spots today, but no more itching.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: Pfizer given as second dose.  Moderna given as first dose
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 16 days after 1st dose
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Dizziness, headache, body aches, chills, nausea, Low grade fever.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Dizziness, headache, body aches, chills, nausea, Low grade fever.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Slight Headache, chills, sore right arm, low fever and tired
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, muscle aches/pains, weakness. Fatigue
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient c/o generalized itching starting on day 1 after covid 19 vaccination- Moderna
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A body rash began after a week and continues to spread. She has had the rash for 10 days and it continues to spread. She has been told to watch for other symptoms and sent home.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Moderna COVID-19 Vaccine EAU A line of red spots along part of my arm  where the shot was given. Started  about 15 minutes after shot and is not going away.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Received second dose of vaccine on 1/18/21. Had contact with +COVID family member. Asymptomatic but COVID  tested on 2/13/21 and was negative. 2/16/21 came to ED with fever that had developed. COVID tested again with + result
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pruritus, Rash erythematous
Clinical narrative: red rash at injection site and bruise , itching
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: AFTER RECEIVING THE VACCINE SHE STARTED COMPLAINING OF DIZZINESS AND LIGHTHEADINESS. ON SITE EMS RESPONDED. VITALS ARE BELOW. SHE WAS TREATED AND RELEASED TO HOME
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Starting Thursday night (2/18/2021) my arm became extremely itchy. When I woke up this morning (2/19/2021) my arm was swollen, red and stilly itchy at the injection site. This is a week after the shot was given.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: patient indicated she noticed swelling in entire left side of face and neck no redness or rash swelling including lips not tongue
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Soft tissue swelling, Swelling face, Swelling of eyelid, Tenderness
Clinical narrative: patient indicated she noticed swelling in entire left side of face and neck no redness or rash swelling including lips not tongue
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Pollakiuria
Clinical narrative: Approximately 24 hours following my vaccine I developed urinary frequency. In a 12 hour period, I urinated somewhere between 40-50 minutes. Approximately once every 10-15 minutes. I have never had frequency in my life. By the following morning, it was completely gone. I have spoken to friends, and two friends developed similar symptoms. One female. One male. Same age group. I do not see this reported in any literature.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt called this morning stating that she has had a high fever all night, chills, nausea with vomiting and not being able to get out of bed.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood urea increased, Fluid retention
Clinical narrative: Accumulation of fluid in tissues.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Computerised tomogram, Dysgeusia, Lymphadenopathy
Clinical narrative: Client noticed pain in her neck, left axillary and left shoulder. Had a CT scan two weeks ago that revealed enlarged lymph nodes. Still having pain with enlarged lymph nodes today on 2/19/21. Also stated that she had a metallic taste in her mouth when receiving the first dose of the Pfizer vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Client noticed pain in her neck, left axillary and left shoulder. Had a CT scan two weeks ago that revealed enlarged lymph nodes. Still having pain with enlarged lymph nodes today on 2/19/21. Also stated that she had a metallic taste in her mouth when receiving the first dose of the Pfizer vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest pain, Coronary artery disease, Death, Dyspnoea
Clinical narrative: Patient received first dose of covid vaccine on 1/22/2021.  Patient had no immediate reaction.  Patient presented  to the Emergency Department on 1/26/2021 c/o shortness of breath and chest pain. ECG showed a ST elevation myocardial infarction.  Patient was treated and transferred to a cath lab where he died.  Patient had significant coronary artery disease.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation
Clinical narrative: Patient received first dose of covid vaccine on 1/22/2021.  Patient had no immediate reaction.  Patient presented  to the Emergency Department on 1/26/2021 c/o shortness of breath and chest pain. ECG showed a ST elevation myocardial infarction.  Patient was treated and transferred to a cath lab where he died.  Patient had significant coronary artery disease.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itching  and tingling began ten minutes after administration, stated itching to body and lips
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Gait inability, Migraine, Nausea
Clinical narrative: Migraines, Fever of 100.7 for 5th day, Severe body pain The day following (unable to walk without assistance)  nausea, Light Headed, Unable to focus
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Migraines, Fever of 100.7 for 5th day, Severe body pain The day following (unable to walk without assistance)  nausea, Light Headed, Unable to focus
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Spider web like red mark all over lower back
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: COVID-19 Vaccine EUA. I have had a swollen, sore lymph node in my left armpit since Tuesday. I understand this is one of the possible side effects so I have not yet sought out medical treatment. If it is still swollen and sore in a few days, I will check up on it.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Decreased appetite, Fall, Fatigue
Clinical narrative: Patient reports at least two falls following COVID vaccine.  Requiring assistance to stand up.  Legs reported as "giving out" resulting in falls.  Reports being shaking within 24 hours following vaccination.  Reports extreme weakness and needing to be lowered to the floor at least twice.  This is new for him.  Did not report feeling dizzy; blood sugar was reported as normal during the time.  No confusion or feeling out of it reported at the time. Ended up with abrasions.  Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday.  Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030.  Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved.  Assessment    1. Fall from standing, initial encounter    2. Multiple abrasions    3. Adverse effect of vaccine, initial encounter    4. Generalized weakness  PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility  PT EVAL AND TREAT   I suspect his falls and weakness are due to Covid-19 vaccine reaction.  I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain.  Feeling better overall today.  Recommended getting up every 2 hours to walk around, use walker for now.  Call if more falls or continued extreme weakness.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injury, Mobility decreased, Muscular weakness, Skin abrasion, Tremor
Clinical narrative: Patient reports at least two falls following COVID vaccine.  Requiring assistance to stand up.  Legs reported as "giving out" resulting in falls.  Reports being shaking within 24 hours following vaccination.  Reports extreme weakness and needing to be lowered to the floor at least twice.  This is new for him.  Did not report feeling dizzy; blood sugar was reported as normal during the time.  No confusion or feeling out of it reported at the time. Ended up with abrasions.  Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday.  Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030.  Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved.  Assessment    1. Fall from standing, initial encounter    2. Multiple abrasions    3. Adverse effect of vaccine, initial encounter    4. Generalized weakness  PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility  PT EVAL AND TREAT   I suspect his falls and weakness are due to Covid-19 vaccine reaction.  I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain.  Feeling better overall today.  Recommended getting up every 2 hours to walk around, use walker for now.  Call if more falls or continued extreme weakness.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urine output decreased, Walking aid user
Clinical narrative: Patient reports at least two falls following COVID vaccine.  Requiring assistance to stand up.  Legs reported as "giving out" resulting in falls.  Reports being shaking within 24 hours following vaccination.  Reports extreme weakness and needing to be lowered to the floor at least twice.  This is new for him.  Did not report feeling dizzy; blood sugar was reported as normal during the time.  No confusion or feeling out of it reported at the time. Ended up with abrasions.  Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday.  Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030.  Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved.  Assessment    1. Fall from standing, initial encounter    2. Multiple abrasions    3. Adverse effect of vaccine, initial encounter    4. Generalized weakness  PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility  PT EVAL AND TREAT   I suspect his falls and weakness are due to Covid-19 vaccine reaction.  I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain.  Feeling better overall today.  Recommended getting up every 2 hours to walk around, use walker for now.  Call if more falls or continued extreme weakness.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Nodule, Swelling
Clinical narrative: Had knot the size of grape on arm till 15th or 16 it went away till the 19th it came back. On the 16th i started to have swelling in my arm pit. Treated by pcp the 19th resolved by the 22nd. The month of january.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: She had the first dose before she was 19 years old/ boosted dose 0.5 ml; She had the first dose before she was 19 years old/ boosted dose 0.5 ml; no adverse events; After giving the vaccine I noticed it expired on 01/09/2021; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, before the age of 19 years old, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose, route of administration, lot # and expiration date were unknown) for prophylaxis. On 03-FEB-2021, the patient was vaccinated with the second booster expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # S034296 with expiration date on 09-JAN-2021 (route of administration was unknown) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; 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
Sex: U
Vaccine: HPV9, RV5
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: administration of vaccines involved during a temperature excursion; no adverse event; This spontaneous report was received from a medical assistant and refers to unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with incorrectly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # S033308 with expiration date on 08-APR-2022 (route of administration was unknown) and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, orally, lot # 1684157 with expiration date on 23-JUN-2021, both for prophylaxis. The suspected vaccines underwent temperature excursions of 1.8 degrees Celsius for 30 minutes, 1.1 degrees Celsius for 30 minutes and 1.7 degrees Celsius for 30 minutes on unknown dates. No additional adverse events reported. 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: S033308; expirationdate: 08-APR-2022; 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
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, General physical health deterioration, Hypertension, Irritable bowel syndrome, Migraine
Clinical narrative: lupus; rheumatoid arthritis; cervical cancer requiring hysterectomy by the age of 24; severe (also reported as several) autoimmune diseases; raynauds; POTS; inappropriate sinus tachycardia; high blood pressure; intractable migraines; food intolerances to red meat and dairy; food intolerances to red meat and dairy; IBS; health continues to deteriorate; This spontaneous report was received via social media monitoring from a lawyer, regarding an on-line article authored by the lawyer that involved a lawsuit (case in litigation), and refers to a 17-year-old female patient (pt) whose age at vaccination with the suspect vaccine was not provided. The pt's pertinent medical history, concomitant medications or drug reactions/allergies were not not provided.  On an unknown date, the pt consented and was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (also referred to as "Gardasil human papillomavirus (HPV) vaccine") (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient reacted to the suspect vaccine developing severe (also reported as several) autoimmune diseases, lupus, rheumatoid arthritis, Raynauds, postural orthostatic tachycardia syndrome (POTS), inappropriate sinus tachycardia, high blood pressure, intractable migraines, food intolerances to red meat and dairy, irritable bowel syndrome (IBS), cervical cancer requiring hysterectomy by the age of 24, and the pt's health continued to deteriorate. The pt inquired a physician about how to have her blood tested for the presence of the HPV-16 L1 fragment and any costs associated with that testing. The pt stated she had been unable to find treatment or recovery as her health continued to deteriorate.  The outcome of the events was not recovered/not resolved (provided as present status: not recovered). The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (provided as reacted to the suspect vaccine developing the reported events).  Upon internal review, the events of autoimmune disorder, cervix carcinoma, rheumatoid arthritis, and systemic lupus erythematosus were determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA011807:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Raynaud's phenomenon, Rheumatoid arthritis, Sinus tachycardia, Systemic lupus erythematosus
Clinical narrative: lupus; rheumatoid arthritis; cervical cancer requiring hysterectomy by the age of 24; severe (also reported as several) autoimmune diseases; raynauds; POTS; inappropriate sinus tachycardia; high blood pressure; intractable migraines; food intolerances to red meat and dairy; food intolerances to red meat and dairy; IBS; health continues to deteriorate; This spontaneous report was received via social media monitoring from a lawyer, regarding an on-line article authored by the lawyer that involved a lawsuit (case in litigation), and refers to a 17-year-old female patient (pt) whose age at vaccination with the suspect vaccine was not provided. The pt's pertinent medical history, concomitant medications or drug reactions/allergies were not not provided.  On an unknown date, the pt consented and was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (also referred to as "Gardasil human papillomavirus (HPV) vaccine") (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient reacted to the suspect vaccine developing severe (also reported as several) autoimmune diseases, lupus, rheumatoid arthritis, Raynauds, postural orthostatic tachycardia syndrome (POTS), inappropriate sinus tachycardia, high blood pressure, intractable migraines, food intolerances to red meat and dairy, irritable bowel syndrome (IBS), cervical cancer requiring hysterectomy by the age of 24, and the pt's health continued to deteriorate. The pt inquired a physician about how to have her blood tested for the presence of the HPV-16 L1 fragment and any costs associated with that testing. The pt stated she had been unable to find treatment or recovery as her health continued to deteriorate.  The outcome of the events was not recovered/not resolved (provided as present status: not recovered). The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (provided as reacted to the suspect vaccine developing the reported events).  Upon internal review, the events of autoimmune disorder, cervix carcinoma, rheumatoid arthritis, and systemic lupus erythematosus were determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA011807:
Sex: U
Vaccine: PPV
Symptoms: Intercepted product administration error, No adverse event
Clinical narrative: No additional AE reported; Pharmacist was aware that the vial should contain 0.5 mililiters for a full dose, so decision was made not to vaccinate patient; Pharmacist was aware that the vial should contain 0.5 mililiters for a full dose, so decision was made not to vaccinate patient; Pharmacist withdrew solution from involved vial and found that it measured just over 0.3 milliliter in her syringe. Pharmacist was aware that the vial should contain 0.5 mililiter for a full dose; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, the patient was supposed to receive a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 milliliter (one vial), lot # T024556, expiration date 08-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The pharmacist withdrew solution from the involved vial and found that it measured just over 0.3 milliliters in her syringe. The reporter was aware that the vial should contain 0.5 milliliters for a full dose, so decision was made not to vaccinate the patient and instead, the solution was returned to the vial (underfilled vial). No other defects were noted by pharmacist.   The reporter stated that the rubber stopper was present and it did not appear to be protruding from the vial, it was flush like normal. The crimp (metal seal) was on tightly and properly and there was no evidence of cracks or breakage on the vial. There was no leaking noticed and the reporter also noted that there was no residue of any past leakage. The vial flip cap was in place when received, but was removed when withdrawing contents. There was no evidence that the stopper has a puncture mark. The pharmacist stated, that the meniscus of liquid was at bottom of label; the reporter had to slightly peel label to view liquid level. At the reporting time, the pharmacist did not have any other vials to compare to. The vial was determined to be underfilled after withdrawing the contents with a syringe; the vial appeared to be underfilled by about 0.2 ml per calculation. The pharmacist used 3 ml syringe (BD Precision Glide Luer-Lock Syringe), 25 gauge. The pharmacist also had another pharmacist withdraw the solution with a different syringe/needle (of same manufacture) and found the same result. The vial was inverted while withdrawing the solution. The entire volume in the vial could be removed. Prior to withdrawing, an equal volume of air (0.5 ml) was injected to the vial. No pressure or resistance was noticed when withdrawing the product in that the product sprayed out of needle insertion site or from around the crimp and stopper.   No adverse event (AE) was reported.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Biopsy skin abnormal, Condition aggravated, Erythema, Granuloma annulare, Rash
Clinical narrative: bumps on the hands and neck/1 or 2 bumps in the crook of his arm/ both arms to the hands/ on the back of his hands/ 4 or 5 on each hand to 25 on each hand/skin rash; The bumps on the back of his hands / are a deeper red / used to be more flesh colored; Condtion aggrivated; was diganosed with Granuloma annulare; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult with an associated reaction of rash papular (1st dose received on 13th January 2020, experienced raised rash refer case US2020252584).   On 13th February 2020, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 22nd April 2020, 69 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced granuloma annulare and rash. On an unknown date, the patient experienced raised rash, erythema and condition aggravated. On an unknown date, the outcome of the granuloma annulare, raised rash, erythema, condition aggravated and rash were unknown.   It was unknown if the reporter considered the granuloma annulare, raised rash, erythema, condition aggravated and rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   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: After vaccination, bumps continued to progress on the hands and neck of the patient. On 9th April 2020, the patient saw the dermatologist who prescribed stronger topical. On 22nd April 2020, the physician did a biopsy and the patient was diagnosed with Granuloma annulare. The neck area had almost completely cleared after that time but has returned. 1 or 2 bumps presented in the crook of the patient's arm and now had gone down both arms to the hands. The bumps on the back of his hands went from 4 or 5 on each hand to 25 on each hand and were a deeper red. They used to be more flesh colored. The patient opted not to get his third dose, due to adverse event from 2nd dose. The reporter stated that the patient received some other vaccines in preparation for a trip to another country but the bumps definitely presented after getting Twinrix not the other vaccines. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash papular
Clinical narrative: bumps on the hands and neck/1 or 2 bumps in the crook of his arm/ both arms to the hands/ on the back of his hands/ 4 or 5 on each hand to 25 on each hand/skin rash; The bumps on the back of his hands / are a deeper red / used to be more flesh colored; Condtion aggrivated; was diganosed with Granuloma annulare; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult with an associated reaction of rash papular (1st dose received on 13th January 2020, experienced raised rash refer case US2020252584).   On 13th February 2020, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 22nd April 2020, 69 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced granuloma annulare and rash. On an unknown date, the patient experienced raised rash, erythema and condition aggravated. On an unknown date, the outcome of the granuloma annulare, raised rash, erythema, condition aggravated and rash were unknown.   It was unknown if the reporter considered the granuloma annulare, raised rash, erythema, condition aggravated and rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   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: After vaccination, bumps continued to progress on the hands and neck of the patient. On 9th April 2020, the patient saw the dermatologist who prescribed stronger topical. On 22nd April 2020, the physician did a biopsy and the patient was diagnosed with Granuloma annulare. The neck area had almost completely cleared after that time but has returned. 1 or 2 bumps presented in the crook of the patient's arm and now had gone down both arms to the hands. The bumps on the back of his hands went from 4 or 5 on each hand to 25 on each hand and were a deeper red. They used to be more flesh colored. The patient opted not to get his third dose, due to adverse event from 2nd dose. The reporter stated that the patient received some other vaccines in preparation for a trip to another country but the bumps definitely presented after getting Twinrix not the other vaccines. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Achiness; Soreness at site of vaccination; Shivering; Headache; Fever; Vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, injection site pain, shivering, headache, fever, vomiting and diarrhea. On an unknown date, the outcome of the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years old. The patient received the first vaccination round of Shingrix in July and felt some of the listed reactions like achiness, soreness at site of vaccination, chills ,shivering, headache, fever, vomiting, and diarrhea. The reporter had consented to follow-up but was unable to contact reporter after corresponding phone attempts, hence follow-up is denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245362:same reporter, same suspect, same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Achiness; Soreness at site of vaccination; Shivering; Headache; Fever; Vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, injection site pain, shivering, headache, fever, vomiting and diarrhea. On an unknown date, the outcome of the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain, injection site pain, shivering, headache, fever, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years old. The patient received the first vaccination round of Shingrix in July and felt some of the listed reactions like achiness, soreness at site of vaccination, chills ,shivering, headache, fever, vomiting, and diarrhea. The reporter had consented to follow-up but was unable to contact reporter after corresponding phone attempts, hence follow-up is denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245362:same reporter, same suspect, same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was not recovered/not resolved.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient felt awful during the night and on the day of reporting after receiving Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatosis, Rash
Clinical narrative: Several irruptions /along a dermatome / these eruptions have not gone away; This case was reported by a other health professional via interactive digital media and described the occurrence of eruption in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced eruption. On an unknown date, the outcome of the eruption was not recovered/not resolved.   It was unknown if the reporter considered the eruption to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's husband. The age at vaccination was not reported. About eight weeks before the date of reporting in 2020, the patient received Shingrix. After receiving Shingrix, the patient had several irruptions that are along a dermatome and these eruptions have not gone away.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: Triggered the contact dermatitis on the right elbow /  in the forearm area of his right arm; This case was reported by a consumer via call center representative and described the occurrence of contact dermatitis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of folliculitis (1st dose received on 11th September 2020 intramuscularly in right arm and the patient experienced contact dermatitis, skin discoloration, milia, scratch, erythema, blister and injection site pain, refer link case US2020254962.). Concurrent medical conditions included diabetes.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced contact dermatitis. The patient was treated with ammonium lactate (Ammonium Lactate 12%). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the contact dermatitis was recovering/resolving.   It was unknown if the reporter considered the contact dermatitis to be related to Shingrix.  Additional details were provided as follows:  four to five days following the shot, while resting his right elbow on a bar the patient experienced contact dermatitis on the right elbow and later that day he rested his forearms on the table and contact dermatitis presented in the forearm area of his right arm where it has rested against the table. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254962:Same reporter
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: developed shingles; 45-year-old female patient  was administrated with Shingrix; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 45-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th October 2019, reference case US2021034614).   On 21st January 2020, the patient received the 2nd dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine at the age of 45 years old, which led to inappropriate age at vaccine administration. The patient developed shingles after 2nd dose and she was recovered from the shingles. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034614:same reporter