chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-AUG-2020, the patient was vaccinated with improperly stored VARIVAX injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T002848, expiration date 23-JAN-2022) as prophylaxis (product storage error). No further adverse event information provided.  The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.56F) for 50 minutes. There was a previous temperature excursion between 6F to 14F (8.47F) for 30 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000749:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The patient had syncopal episode after first dose; The patient had syncopal episode after other dose of vaccine; This spontaneous report was received from an office manager via company representative and refers to a 14 year old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.  On unknow date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for routine immunization. After vaccination the patient had syncopal episode (syncope).  On 04-AUG-2020, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for routine immunization.  On the same date after vaccination, the patient had syncopal episode (syncope) again.  The outcome of the events and the relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were unknown.   Upon internal review, syncope was determined to be medically significant.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye pain, Ocular discomfort, Ocular hyperaemia, Uveitis
Clinical narrative: Uveitis; Eye inflammation; eye redness; eye pain; eye pressure; blurred vision; This case was reported by a other health professional and described the occurrence of uveitis in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 10th July 2020, the patient received the 1st dose of Shingrix. On 20th July 2020, 10 days after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)). On an unknown date, the outcome of the uveitis, eye red, eye pain, sensation of pressure in eye and blurred vision were unknown and the outcome of the eye inflammation was not recovered/not resolved.   It was unknown if the reporter considered the uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient exerianced uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was having no symptoms at time of vaccination.  The patient was asking, if the patient would be able to get 2nd half of vaccination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Uveitis; Eye inflammation; eye redness; eye pain; eye pressure; blurred vision; This case was reported by a other health professional and described the occurrence of uveitis in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 10th July 2020, the patient received the 1st dose of Shingrix. On 20th July 2020, 10 days after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)). On an unknown date, the outcome of the uveitis, eye red, eye pain, sensation of pressure in eye and blurred vision were unknown and the outcome of the eye inflammation was not recovered/not resolved.   It was unknown if the reporter considered the uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient exerianced uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was having no symptoms at time of vaccination.  The patient was asking, if the patient would be able to get 2nd half of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chest pain, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram pelvis
Clinical narrative: renal mass; Diarrhea; Vomiting; Nausea; Abdominal pain; Right anterior chest pain; shortness of breath; This case was reported by a physician via call center representative and described the occurrence of renal mass in a 89-year-old male patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   The patient's past medical history included colon cancer. Concurrent medical conditions included pleural effusion (right plural effusion), renal mass, atrial fibrillation, renal anemia (anemia due to kidney disease), restrictive pulmonary disease, cardiac failure, renal disease (Stage 4 kidney disease) and monoclonal gammopathy.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2020, 3 days after receiving Shingrix, the patient experienced renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath. The patient was treated with ondansetron (Zofran), acetylsalicylic acid (Aspirin) and glyceryl trinitrate (Nitroglycerin). On 28th July 2020, the outcome of the diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath were recovered/resolved. On an unknown date, the outcome of the renal mass was not recovered/not resolved.   It was unknown if the reporter considered the renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath to be related to Shingrix.   Additional details were provided as follows: The patient history includes: restrictive lung disease, heart failure, stage 4 kidney disease, atrial fibrillation, colon cancer, monoclonal gammopathy, right plural effusion, and anti-coagulation therapy.  On the morning of 27th July 2020, the patient began to experienced shortness of breath, abdominal pain, nausea, vomiting, and diarrhea and by that evening the patient complained of right anterior chest pain and was transported via ambulance to the emergency room.  The patient was treated with IV fluids, 4mg Zofran, 325 mg Asprin, and Nitroglycerin tablet. EKG test performed results were normal for patient's medical history. CT scan performed of abdomen and pelvis, no findings. Contributing to abdominal pain, however subsequent finding showed a renal mass. The patient discharged home 2 hours after arrival and the shortness of breath, abdominal pain, nausea, vomiting, diarrhea and right anterior chest pain fully resolved.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dyspnoea, Electrocardiogram normal, Nausea, Renal mass
Clinical narrative: renal mass; Diarrhea; Vomiting; Nausea; Abdominal pain; Right anterior chest pain; shortness of breath; This case was reported by a physician via call center representative and described the occurrence of renal mass in a 89-year-old male patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   The patient's past medical history included colon cancer. Concurrent medical conditions included pleural effusion (right plural effusion), renal mass, atrial fibrillation, renal anemia (anemia due to kidney disease), restrictive pulmonary disease, cardiac failure, renal disease (Stage 4 kidney disease) and monoclonal gammopathy.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2020, 3 days after receiving Shingrix, the patient experienced renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath. The patient was treated with ondansetron (Zofran), acetylsalicylic acid (Aspirin) and glyceryl trinitrate (Nitroglycerin). On 28th July 2020, the outcome of the diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath were recovered/resolved. On an unknown date, the outcome of the renal mass was not recovered/not resolved.   It was unknown if the reporter considered the renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath to be related to Shingrix.   Additional details were provided as follows: The patient history includes: restrictive lung disease, heart failure, stage 4 kidney disease, atrial fibrillation, colon cancer, monoclonal gammopathy, right plural effusion, and anti-coagulation therapy.  On the morning of 27th July 2020, the patient began to experienced shortness of breath, abdominal pain, nausea, vomiting, and diarrhea and by that evening the patient complained of right anterior chest pain and was transported via ambulance to the emergency room.  The patient was treated with IV fluids, 4mg Zofran, 325 mg Asprin, and Nitroglycerin tablet. EKG test performed results were normal for patient's medical history. CT scan performed of abdomen and pelvis, no findings. Contributing to abdominal pain, however subsequent finding showed a renal mass. The patient discharged home 2 hours after arrival and the shortness of breath, abdominal pain, nausea, vomiting, diarrhea and right anterior chest pain fully resolved.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: renal mass; Diarrhea; Vomiting; Nausea; Abdominal pain; Right anterior chest pain; shortness of breath; This case was reported by a physician via call center representative and described the occurrence of renal mass in a 89-year-old male patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   The patient's past medical history included colon cancer. Concurrent medical conditions included pleural effusion (right plural effusion), renal mass, atrial fibrillation, renal anemia (anemia due to kidney disease), restrictive pulmonary disease, cardiac failure, renal disease (Stage 4 kidney disease) and monoclonal gammopathy.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2020, 3 days after receiving Shingrix, the patient experienced renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath. The patient was treated with ondansetron (Zofran), acetylsalicylic acid (Aspirin) and glyceryl trinitrate (Nitroglycerin). On 28th July 2020, the outcome of the diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath were recovered/resolved. On an unknown date, the outcome of the renal mass was not recovered/not resolved.   It was unknown if the reporter considered the renal mass, diarrhea, vomiting, nausea, abdominal pain, chest pain and shortness of breath to be related to Shingrix.   Additional details were provided as follows: The patient history includes: restrictive lung disease, heart failure, stage 4 kidney disease, atrial fibrillation, colon cancer, monoclonal gammopathy, right plural effusion, and anti-coagulation therapy.  On the morning of 27th July 2020, the patient began to experienced shortness of breath, abdominal pain, nausea, vomiting, and diarrhea and by that evening the patient complained of right anterior chest pain and was transported via ambulance to the emergency room.  The patient was treated with IV fluids, 4mg Zofran, 325 mg Asprin, and Nitroglycerin tablet. EKG test performed results were normal for patient's medical history. CT scan performed of abdomen and pelvis, no findings. Contributing to abdominal pain, however subsequent finding showed a renal mass. The patient discharged home 2 hours after arrival and the shortness of breath, abdominal pain, nausea, vomiting, diarrhea and right anterior chest pain fully resolved.  The reporter consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: five dime sized, red "splotches" on her left arm near the injection site.; fatigue; sore injection site; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date unknown) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 25th August 2020, the patient experienced fatigue. On 26th August 2020, the patient experienced red blotches. On 27th August 2020, the outcome of the injection site pain and fatigue were recovered/resolved. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in left arm. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced five dime sized, red splotches on her left arm near the injection site, injection site sore and fatigue. The reporter stated that the red splotches were on going. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: have a patient who received the Prevnar 13 vaccine in 2016 and went to a local pharmacy and forgot she had already received it and was given it again last week in 2020.; She is having some arm soreness; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in Aug2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient who previous received the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine in 2016 for immunization and went to a local pharmacy and forgot she had already received it and was given it again last week in Aug2020. Her name is hyphenated so they did not see the first immunization. She was having some arm soreness but other than that was there any cause for concern. The outcome of event was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site; redness and swelling at injection site; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration, in the arm, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and swelling at injection site. It was reported that redness and swelling covered the entire upper portion of her arm. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020341566 same reporter/ drug/ event for different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site; redness and swelling at injection site; This is a spontaneous report obtained from a contactable physician through a sales representative. This physician reported similar events for two patients. This is the second of two reports.   A patient of an unspecified gender and age received PREVENAR 13, Solution for injection in pre-filled syringe via an unspecified route of administration, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and swelling at injection site. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020341302 same reporter/ drug/ event for different patients.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm has significant redness, swelling, pain, increased warmth starting the day after the vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMRV and Varicella given to patient on 09/01/2020
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Varicella vaccine was administered intramuscularly instead of Subcutaneously into the Left Deltoid.  No know adverse reactions known currently
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Blood electrolytes, Chills, Coronavirus test, Electrocardiogram, Fatigue
Clinical narrative: Rather sudden onset of severe headache, severe shaking chills, absence of fever, severe nausea, persistent vomiting. lasting about 4 hours, relieved with zofran.  Tired and muscle aches following day with persistent headache 48 hours
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Headache, Myalgia, Nausea, Tremor
Clinical narrative: Rather sudden onset of severe headache, severe shaking chills, absence of fever, severe nausea, persistent vomiting. lasting about 4 hours, relieved with zofran.  Tired and muscle aches following day with persistent headache 48 hours
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Rather sudden onset of severe headache, severe shaking chills, absence of fever, severe nausea, persistent vomiting. lasting about 4 hours, relieved with zofran.  Tired and muscle aches following day with persistent headache 48 hours
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, shivering , fever, fatigue. My fever spiked at 102 degrees. my symptoms lasted for 36 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Pyrexia, Rash
Clinical narrative: experiencing  fever, chest pain  and has rash all over her left arm
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: Mist came out of the syringe/PQC Present?: Yes/there must have been a crack or something in it because otherwise no mist would come out; the patient had to be "stuck twice"; no other adverse events to the patient; This spontaneous report was received from a physician via a company representative referring to a currently 13 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, when the nurse attempted to administer a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020255, expiration date 09-DEC-2021, indication: prophylaxis; strength and route were not reported) to a patient, she noticed a mist came out of the syringe near the luer lock area while giving the injection, disposed of the syringe in the "sharps container", then gave another injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiration date was not provided) to the patient, since the patient had to be "stuck twice" (syringe issue and incorrect dose administered). The healthcare provider said "there must have been a crack or something in it because otherwise no mist would come out." He stated there was no damage noted to any of the packaging or the syringe itself until the nurse saw the "mist." Product quality compliant involved. The healthcare provider reported they had had no other problems with any of the other pre-filled syringes of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The doctor stated no other adverse events to the patient. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate: manufacturercountry:; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC .; temperature excursion that was intermittent beginning 7/28/2020; This spontaneous report as received from a registered nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-AUG-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, lot # T002843, expiration date 23-JAN-2022 and lot# S032357, expiration date 14-OCT-2021 (strength and doses were not reported) for prophylaxis.  Since 28-JUL-2020, the dose of the vaccine was exposed to temperature excursion at max. -9.5 Celsius degrees (C) for 38 hours and 30 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Nausea, Pyrexia
Clinical narrative: third dose in a female patient  today /  patient recieved another dose; had a temperature; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 444M2, expiry date 10th April 2022) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD) for prophylaxis.   Previously administered products included Shingrix (receivd 1st dose in 2020).   In August 2020, the patient received the 2nd dose of Shingrix. On 27th August 2020, the patient received the 3rd dose of Shingrix. In August 2020, the patient received FLUZONE HD. In August 2020, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and nausea. On 27th August 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the fever, nausea and extra dose administered were unknown.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in unknown arm. The pharmacist wanted information regarding a Shingrix third dose in a patient. The patient received 3rd dose of Shingrix which led to extra dose administered. The reporter stated that in last week the patient received 2nd dose. The first dose was started in year 2020 before coronavirus. The pharmacist reported that patient over the past week following dose 2 felt like she had a temperature and experienced nausea. The patient also got a Fluzone HD shot the day of 2nd dose of shingrix but in different arms. The reporter consented to follow up. It was unknown if the reporter considered the fever and nausea to be related to Fluzone HD.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills, fever, fatigue, muscle soreness
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: PATIENT CALLED ME TODAY , 9/4/2020 SAYING THAT HE WAS TIRED YESTERDAY AFTER HE WENT HOME AFTER GETTING THE FKU SHOT HOWEVER HE DID NOT HAVE FEVER  ALOS HE WAS SO EXHAUSTED , TODAY HE IS NORMAL NO SYMPTOMS AS YESTERDAY
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, edema, and warmth inferior to the injection site on the left deltoid
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient received HPV dose 1, left deltoid, IM. After receiving the vaccine the patient had a syncope episode.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm (bicep area) became swollen, very sore and very red about 9:00 PM. Took 2 Tylenol and went to bed about 10:00 PM, had chills and ran temperature. Woke up about 1:00 AM and took temperature with Infrared thermometer, 100 degrees at forehead and 103 at arm.  Took 2 Tylenol and went back to bed.  By Thursday, Sep 3 arm was better but still not 100%.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills, shivering, headache, muscle ache, head ache.
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Axillary nerve injury, Burning sensation, Bursal fluid accumulation, Cervical radiculopathy, Electromyogram abnormal
Clinical narrative: Left axillary nerve injury
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Magnetic resonance imaging abnormal, Mononeuropathy
Clinical narrative: Left axillary nerve injury
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Nasopharyngitis, Nerve conduction studies abnormal, Neuropathy peripheral, Paraesthesia, Rotator cuff syndrome
Clinical narrative: Left axillary nerve injury
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Tendon disorder, Vaccination complication, X-ray limb abnormal
Clinical narrative: Left axillary nerve injury
Age: 36.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Axillary nerve injury, Nerve conduction studies abnormal
Clinical narrative: Left axillary nerve injury
Age: 68.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Eye pain, Nausea, Ophthalmological examination, Visual impairment
Clinical narrative: The following day noticed problem seeing with bright light--extreme pain with any light--continued for 4 days--called Dr on Monday 31 and made appt with eye doctor on Monday--Pressure in both eyes elevated 50+--Last eye examination one month prior was  normal.  Will return to see her Tuesday morning 9/8 as followup.   Better today--nauseated and painful pressure in right eye today
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: I gave the shingles vaccine in the right deltoid and after administration, the injection site swelled up into a lump in the next minute. Swelling had gone down when patient came in 3 days later for tetanus vaccine.  Unknown if patient went to see a doctor about the adverse event.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient caregiver called pharmacy explaining patient has left arm reaction (shingrix vaccine was given in this arm) of: orange-sized ball, warm to touch, red and swollen. They stated that the had marked the reaction site the day prior (9/3/2020) to calling pharmacy and the reaction site had grown by 3-4 inches since the mark was placed. Caregiver was instructed to take patient to Urgent Care/ER as soon as possible to be seen for reaction. Phone call was received 9/4/2020 at 10:47am to myself (who doesn't typically work at this facility). I decided to report incident since I was unsure if it could be allergic.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Chills all night, fever of 100.3 the next morning at 8 am. Extreme headache, stomach pain and nausea, very sore arm at injection site, but not swollen.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: Chills all night, fever of 100.3 the next morning at 8 am. Extreme headache, stomach pain and nausea, very sore arm at injection site, but not swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: She developed a "knot" under the skin almost immediately after the injection.  Within 2 hours, her injection site was erythematous, swollen and "feverish."  She presented to the local ER for treatment.  She was diagnosed with cellulitis of the arm and was given Keflex 500mg QID x 7 days.  No anaphylaxis.  Her arm has continued to be painful to move and the erythema, swelling and fever has moved down to mid-humeral to elbow.  No joint pain in elbow.  She saw her PCP  today and her antibiotics were changed to Clindamycin 300mg QID x 10 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: She developed a "knot" under the skin almost immediately after the injection.  Within 2 hours, her injection site was erythematous, swollen and "feverish."  She presented to the local ER for treatment.  She was diagnosed with cellulitis of the arm and was given Keflex 500mg QID x 7 days.  No anaphylaxis.  Her arm has continued to be painful to move and the erythema, swelling and fever has moved down to mid-humeral to elbow.  No joint pain in elbow.  She saw her PCP  today and her antibiotics were changed to Clindamycin 300mg QID x 10 days.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Tender/ hard to touch at injection site Advised to use Motrin, Benadryl & ice as needed F/u if symptoms persist or worsen
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fatigue & Body Aches started at the end of Day 7. Fever manifested the following morning. Fever peaked on Day 8 at 100.3 degrees and returned to normal on Day 9.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Cough, Crying, Urticaria
Clinical narrative: coughing; crying; broke out in hives; This spontaneous report was received from a nurse and refers to a 4 month old male patient with prophylaxis. His concomitant therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR), hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) and omeprazole. The patient had no previous drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was reported.   On 25-JUN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose 1, 2 milliliter orally, lot number 1660974 was verified to be valid, expiration date reported and validated as 20-APR-2021 for prophylaxis. On 26-AUG-2020, the patient was vaccinated with the second dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter orally, lot number 1660974 was verified to be valid, expiration date reported and validated as 20-APR-2021 for prophylaxis.  On the same day, the patient started to cough, cry and broke out in hives. The patient was taken to an emergency room. There was no laboratory diagnostics or studies performed. It was reported that the therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not discontinued. The outcome of the events was unknown.  The causality assessment between the events and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was not provided.  The reporter considered the events of urticaria, cough and crying to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Eczema, Eye pain, Eye swelling, Eyelid oedema
Clinical narrative: Hearing loss; Peripheral neuropathy; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Eyelid edema; Tinnitus / Ringing ears; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Information has been received from a lawyer, referring to a patient (pt) of unknown age and gender. Information regrading the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or around 10-DEC-2013, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date,  the pt was diagnosed with peripheral neuropathy and epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest. Furthermore, was additionally diagnosed with tinnitus, consisting of hearing loss and ringing in the ears, as well as eyelid edema, consisting of pain and swelling of his eyes and eyelid. As a direct and proximate result of a defective zoster vaccine live(ZOSTAVAX), the patient had resulted in physical limitation not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral was unknown.     The lawyer considered deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events deafness and neuropathy peripheral were determined to be medically significant and serious due to disabling criteria. The events tinnitus, eyelid oedema, perivascular dermatitis, eyelid pain, eye swelling, eye pain and eczema were determined to be serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Eyelid pain, Neuropathy peripheral, Pain, Perivascular dermatitis, Pustule
Clinical narrative: Hearing loss; Peripheral neuropathy; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Eyelid edema; Tinnitus / Ringing ears; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Information has been received from a lawyer, referring to a patient (pt) of unknown age and gender. Information regrading the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or around 10-DEC-2013, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date,  the pt was diagnosed with peripheral neuropathy and epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest. Furthermore, was additionally diagnosed with tinnitus, consisting of hearing loss and ringing in the ears, as well as eyelid edema, consisting of pain and swelling of his eyes and eyelid. As a direct and proximate result of a defective zoster vaccine live(ZOSTAVAX), the patient had resulted in physical limitation not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral was unknown.     The lawyer considered deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events deafness and neuropathy peripheral were determined to be medically significant and serious due to disabling criteria. The events tinnitus, eyelid oedema, perivascular dermatitis, eyelid pain, eye swelling, eye pain and eczema were determined to be serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Swelling of eyelid, Tinnitus
Clinical narrative: Hearing loss; Peripheral neuropathy; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest; Eyelid edema; Tinnitus / Ringing ears; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Consisting of pain and swelling of his eyes and eyelids; Information has been received from a lawyer, referring to a patient (pt) of unknown age and gender. Information regrading the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or around 10-DEC-2013, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date,  the pt was diagnosed with peripheral neuropathy and epidermal spongiosis associated with lymphocytic exocytosis, consisting of burning pain, rashes and pustules across his arms, legs, face, scalp, back and chest. Furthermore, was additionally diagnosed with tinnitus, consisting of hearing loss and ringing in the ears, as well as eyelid edema, consisting of pain and swelling of his eyes and eyelid. As a direct and proximate result of a defective zoster vaccine live(ZOSTAVAX), the patient had resulted in physical limitation not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral was unknown.     The lawyer considered deafness, eyelid pain, eye swelling, eye pain, tinnitus, eyelid oedema, perivascular dermatitis, eczema and neuropathy peripheral to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events deafness and neuropathy peripheral were determined to be medically significant and serious due to disabling criteria. The events tinnitus, eyelid oedema, perivascular dermatitis, eyelid pain, eye swelling, eye pain and eczema were determined to be serious due to disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer, referring to a patient (pt) of unknown age and gender. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 25-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dose, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated by a physician at a medical center for shingles (herpes zoster).  As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX) vaccine, the pt had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. Furthermore, pt would experience diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was unknown. The lawyer determined herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect; expired vaccine administered; This initial spontaneous report as received from a nurse refers to a 8 year old patient of an unknown gender. No information regarding patient's concurrent conditions, pertinent medical history, drug allergies and concomitant therapies were provided.   On 28-AUG-2020 the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration were not provided) (lot # S019435, expiration date 23-AUG-2020) for prophylaxis. The nurse reported that the vaccine was administered to child 5 days pasted expiration date and requested to know if it is still safe for the child. The nurse states that the vaccine was stored in proper storage conditions throughout the date of administration. An evaluation of the expired dose of hepatitis a vaccine, inactivated VAQTA was provided to the nurse. No additional adverse effects reported.    combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability